FDA's approval of Biogen's aducanumab for Alzheimer's stirs debate 

Hope and Controversy

FDA cleared amivantamab-vmjw (Rybrevant, Janssen) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations.

The genetic mutations, called epidermal growth factor receptor (EGFR) exon 20 insertion mutations, are detected by an FDA-approved companion test, Guardant360 CDx (Guardant Health).

Approximately 2% to 3% of patients with non-small cell lung cancer have EGFR exon 20 insertion mutations, which are a group of mutations on a protein that causes rapid cell growth, according the 

about the approval. EGFR exon 20 insertion mutations are the third most common type of EGFR mutation.

Lung cancer’s new drug based on precision medicine

“Today’s FDA approval is an important development for people living with non-small cell lung cancer with exon 20 insertion mutations who, until now, have had no approved treatment options to target their disease,” said Jill Feldman, co-founder of the EGFR Resisters, an advocacy patient group, in a Janssen 

. “We are excited by the promise this new treatment option brings to people with this particular type of lung cancer and their families.”

Advances in precision oncology continue to facilitate drug development, allowing diseases like lung cancer to be subset into biomarker-defined populations appropriate for targeted therapies, said Julia Beaver, MD, chief of medical oncology in the FDA’s Oncology Center of Excellence and acting deputy director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a 

FDA’s accelerated approval was based on a study of the medication’s efficacy in 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.

The overall response rate of patients receiving Rybrevant was 40%. The median duration of response was 11.1 months, with 63% of patients having a duration of response of 6 months or more.

FDA previously granted Breakthrough Therapy Designation (BTD) to Rybrevant in March 2020 and initiated a Priority Review of the Biologics License Application (BLA) in December 2020.

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About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.

FDA OKs first targeted therapy for lung cancer with certain type of EGFR mutations

FDA approved pegcetacoplan (Empaveli, Apellis), the first and only targeted C3 therapy for treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)

PBM OptumRx had identified the medication as 

one of the top 5 drugs that will have an impact this year

 in its Drug Pipeline Insights Report, saying it could become the market leader in PNH treatments.

Top 5 drugs in the pipeline that could have an impact this year

PNH is a rare, chronic, life-threatening blood disorder caused by an acquired mutation, which leads to uncontrolled complement activation and the destruction of red blood cells through intravascular and extravascular hemolysis.

Empaveli is approved for adults with PNH who are treatment naïve as well as patients switching from the C5 inhibitors eculizumab (Soliris, Alexion Pharmaceuticals) and ravulizumab (Ultomiris, Alexion).

“As the first, FDA-approved targeted C3 therapy, Empaveli has the potential to redefine treatment for adults with PNH, including patients switching from any C5 inhibitor and treatment-naïve patients,” said Cedric Francois, M.D., Ph.D., co-founder and CEO of Apellis, in a 

. “This approval represents a major scientific advancement as Empaveli ushers in the first new class of complement medicine in almost 15 years.”

Novel pair of therapies offers hope to patients with rare blood disorders

Empaveli has the potential to improve the lives of patients with PNH by increasing hemoglobin and reducing blood transfusion requirements, added Olga Frankfurt, M.D., PEGASUS study investigator and associate professor in the department of medicine, division of hematology and oncology at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

In the head-to-head Phase 3 PEGASUS study, Empaveli met the primary endpoint, demonstrating superiority to Soliris for the change from baseline in hemoglobin level at Week 16 with an adjusted mean increase of 3.84 g/dL of hemoglobin. Notably, 85% of Empaveli-treated patients were didn't need transfusions over 16 weeks versus 15% of Soliris-treated patients

The prescribing information for Empaveli contains a boxed warning that the drug may increase the risk of meningococcal and other serious infections caused by encapsulated bacteria that may become rapidly life threatening or fatal if not recognized and treated early. FDA has approved a risk evaluation and mitigation strategy (REMS) for the treatment.

FDA clears treatment for rare obesity disorders

OptumRx had identified pegcetacoplan as one of the top 5 drugs in the pipeline this year.

FDA OKs first-of-its-kind treatment for paroxysmal nocturnal hemoglobinuria

 said today that their joint COVID-19 vaccine candidate may be available by the end of this year after positive mid-stage results.

The adjuvanted recombinant candidate achieved strong rates of neutralizing antibody responses — 95% to 100% seroconversion — in all adult age groups in a Phase 2 study, the two pharma compnanies said in a joint 

FDA authorizes new COVID-19 treatments; more vaccine doses on the way

The high antibody responses occurred across all doses, with acceptable tolerability and with no safety concerns. “Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old),” Sanofi and GSK said.

In addition, after a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, “suggesting strong potential for development as a booster vaccine,” the companies said.

A global pivotal Phase 3 study is expected to start in the coming weeks.

“Our Phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur. “We look forward to generating additional data and working with our partners around the world to make our vaccine available as quickly as possible.”

Biden stimulus plan beefs up COVID-19 vaccinations and testing

Roger Connor, president of GSK Vaccines, said the pharma makers’ goal is to have the vaccine available before the end of the year. Sanofi has vaccine purchasing agreements in place with the U.S., the EU, Britain and Canada, and the World Health Organization-backed COVAX facility, Reuters 

The Phase 3 trial for the vaccine candidate is expected to enroll more than 35,000 adults from a broad range of countries and will assess the efficacy of two vaccine formulations including the D614 (Wuhan) and B.1.351 (South African) variants.

In parallel, the companies intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine platform received.

FDA okays first combo COVID-19 and flu test

Sanofi and GlaxoSmithKline’s joint COVID-19 vaccine candidate achieved 95% to 100% seroconversion in a Phase 2 study.

Sanofi and GSK’s COVID-19 vaccine may be available this year

Among the most notable new drug approvals that might occur this year include a treatment for Alzheimer’s disease and three new drugs for atopic dermatitis, according to a new report.

Pharmacy benefit manager OptumRx’s Drug Pipeline Insights Report identifies aducanumab (Biogen), pegcetacoplan (Apellis Pharmaceuticals), abrocitinib (Pfizer), tralokinumab (LEO Pharma) and ruxolitinib (Incyte Corporation) as the top 5 drugs in the pipeline.

Aducanumab, which is awaiting the results of an FDA committee’s safety review in early June, is a human monoclonal antibody under development to treat Alzheimer’s disease.

“Several prescription drugs are currently approved to treat the symptoms of Alzheimer’s such as memory loss. If approved, aducanumab would be the first disease modifying therapy for Alzheimer’s disease,” the report said. 

But an advisory committee to the FDA vote against approving aducanumab late last year, and a number of experts have questioned how Biogen is interpreting clinical trial data to support its application.

Abrocitinib is under development to treat moderate-to-severe atopic dermatitis in patients aged 12 years and older. The Janus kinase (JAK) inhibitor medication helps ease inflammation and other related symptoms.

Tralokinumab is another drug for atopic dermatitis, but it acts on interleukin (IL)-13, which plays a key role in driving the underlying chronic inflammation in atopic dermatitis.

In Phase 3 trials, patients were treated with tralokinumab administered subcutaneously every 2 or 4 weeks, and with or without a topical corticosteroid. The results demonstrated efficacy and safety at each interval, with or without the use of a topical corticosteroid.

“If approved, tralokinumab would offer a novel mechanism of action  for moderate-to-severe atopic dermatitis. However…tralokinumab will compete not only with existing treatment options like Dupixent but also, potentially, several JAK inhibitors as well,” said the OptumRx report.

BMS’s Opdivo earns indication for gastric cancer

Ruxolitinib topical cream will treat mild-to-moderate atopic dermatitis in patients aged 12 years and older. The selective JAK inhibitor directly targets two chemical pathways that underlie atopic dermatitis.

If approved, the medication would be the first topical JAK inhibitor for atopic dermatitis. “While oral JAK inhibitors have been associated with serious side effects, the topical form may potentially reduce some of the safety concerns associated with the class. According to the data available, topical ruxolitinib appears to be well tolerated with no major safety issues,” said report from OptumRx, which is a subsidiary of UnitedHealth Group.

Ruxolitinib is currently available as an oral brand (Jakafi) to treat myelofibrosis, polycythemia vera, and graft vs. host disease.

Pegcetacoplan is under development to treat a rare condition, paroxysmal nocturnal hemoglobinuria, which causes the immune system to attack and break down healthy red bloods cells, leading to anemia.

If approved, pegcetacoplan would be the first treatment for the disease to target a different portion of the complement cascade. “There are several differences among these drugs some of which could lead to pegcetacoplan becoming a new market leader for the treatment of PNH,” said OptumRx report.

Blockbuster Farxiga gets new chronic kidney disease indication

The drugs in development include Biogen’s controversial treatment for Alzheimer’s disease and three new drugs for atopic dermatitis.

5 drugs in the pipeline that could have a major impact this year

Teva Pharmaceuticals is launching a generic version of Erythromycin (Arbor Pharmaceuticals), an antibiotic that treats bacterial infections and prevents rheumatic fever attacks in patients allergic to penicillin.

Erythromycin oral tablets boast annual sales of more than $49 million in the U.S., according to IQVIA data, Teva said in a 

.The generic Erythomycin will be available in 250 mg and 500 mg tablets.

FDA clears first treatment for severe hypoglycemia

The pharma maker is also rolling out the first generic of Absorica (isotretinoin) to treat severe recalcitrant nodular acne in patients 12 years and older with multiple inflammatory nodules with a diameter of 5 mm or greater.

Available dosage strengths include 10 mg, 20 mg, 25 mg, 30 mg. and 40 mg.

Sandoz to supply critical generic injectable meds

“Teva’s first-to-market generic version of Absorica (isotretinoin) capsules in the U.S. is an important treatment option for patients living with severe recalcitrant nodular acne, and who are unresponsive to conventional acne therapy including antibiotics,” said Christine Baeder, senior vice president, chief operating officer US Generics, Teva USA, in a 

Isotretinoin oral capsules have annual sales of more than $158 million in the U.S., according to IQVIA data.

Express Scripts accused of overcharging millions of dollar

Teva is making the first generic version of Absorica (isotretinoin), a drug for the treatment of severe acne.

Teva launches its version of erythromycin and Absorica

AstraZeneca’s blockbuster type 2 diabetes Farxiga (dapagliflozin) snagged a new indication for patients with chronic kidney disease at risk of progression with or without type 2 diabetes

The medication, which boasted a sales increase of 54% to $625 million in the first quarter of 2021, is now approved to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalization for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with or without T2D.

Diabetes med Farxiga nabs FDA Priority Review for Chronic Kidney Disease

The approval is “the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Mene Pangalos, executive vice president, of AstraZeneca’s BioPharmaceuticals R&D, in a 

. “We’ve shown impressive efficacy for Farxiga in type 2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease and we are thrilled to be able to bring this medicine to millions of patients in the U.S.”

FDA’s approval was based on positive Phase 3 trial results, which demonstrated that Farxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of CV or renal death by 39%, compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion.

Jardiance to get new heart attack prevention indication

The absolute risk reduction was 5.3% over the median time of 2.4 years. Farxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo, AstraZeneca said.

“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 [sodium glucose co-transporter 2] inhibitor approved for the treatment of chronic kidney disease, regardless of diabetes status. This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease,” said Professor 

with the University Medical Center Groningen, the Netherlands, co-chair of the DAPA-CKD trial and its executive committee.

Drug’s indication expanded to reduce heart attack, stroke risk

The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient  has diabetes.

Blockbuster Farxiga Gets New Chronic Kidney Disease Indication 

U.S. spending on medicines will slow through 2025, while global spending will increase 3-6% annually, according to a new report.

Global drug spending — excluding COVID-19 vaccines — is expected to reach an estimated $1.6 trillion by 2025, according to the 

IQVIA Institute for Human Data Science’s The Global Spending and Usage of Medicines report

The pharmaceutical spending in the U.S. is forecast to grow 0-3% compounded annual growth rate over the next five years, down from 3% CAGR for the past five years, IQVIA predicts.

COVID-19 pushes up prescription drug spending of healthcare systems

Slower projected spending growth can partially be attributed to losses of exclusivity for original brands that will outweigh increased spending on newly launched innovative products. The impact of exclusivity losses will increase to $166 billion over the next five years mostly due to the availability of biosimilars. 

The cumulative savings from biosimilars will reach an estimated $285 billion, according to IQVIA.

However, the U.S. remains “remarkably resilient” in spending trends— particularly after 2021 — registering negligible slowdown compared to previous expectations, according to the research firm.

“While the pandemic has been extremely disruptive, the pre-pandemic forces of medicine use and spending remain significant drivers of the outlook, and these forces have only been modestly impacted by the immediate effects of COVID-19,” said Murray Aitken, IQVIA senior vice president and executive director of IQVIA in a 

. “The success of countries around the world in implementing a global vaccination program — unprecedented in speed and scope — will be key to the outlook for all medicine use through 2025 and beyond.”

Total spending on COVID-19 vaccines through 2025 is projected to be $157 billion, largely focused on the initial wave of vaccinations to be completed by 2022.

Express Scripts report: top drug classes driving spending growth

Meanwhile, the two leading global therapy areas — oncology and immunology — are each forecast to grow 9-12% CAGR through 2025, lifted by significant increases in new treatments and medicine use. Oncology is projected to add 100 new treatments over five years, contributing to a spending hike of more than $100 billion to a total of more than $260 billion in 2025.

Immunology growth is projected to slow from the 17.3% CAGR over the past five years as biosimilars bring lower cost treatments, offsetting growth from volume and drug launches.

Many new therapies are expected in the neurology market including novel migraine therapies, potential treatments for rare neurological diseases, and the potential for therapies for Alzheimer’s and Parkinson’s.

Merck’s experimental drug shows quick reduction in SARS-CoV-2

Global drug spending — excluding COVID-19 vaccines — is expected to reach an estimated $1.6 trillion by 2025, a new report says.

U.S. pharmaceutical spending to slow relative to global trend

The COVID-19 pandemic heavily influenced spending on prescription drugs in the U.S. in 2020 and the pandemic is expected to have a significant impact on drug costs this year and into 2022, according to a new report.

Shifts in care related to the pandemic will continue to be a significant driver of healthcare systems’ drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs, and increased approvals of specialty medications, according to the American Society of Health-System Pharmacists’ (ASHP) 

National Trends in Prescription Drug Expenditures and Projections for 2021

Prescription drug spending in 2020 grew at a moderate rate of 4.9% to $535.3 billion, driven by increased utilization. Spending on new drugs accounted for 1.8% of the increase, and price changes accounted for 0.3%.

Drug spending in nonfederal hospitals declined 4.6%, while drug spending in home care settings increased 13%, the report said.

The top drugs by overall spending were the immunosuppressive adalimumab (Xeljanz) for immune disorders such as arthritis and Crohn's disease; apixaban (Eliquis), a treatment to prevent blood clotting in patients with atrial fibrillation; and the insulin glargine.

Many effects of the pandemic are likely to persist in 2021 and could have a dramatic impact on drug expenditures into 2022, according to Eric Tichy, Pharm.D., lead author of the report and division chair, supply chain management at Mayo Clinic in Rochester, Minn.

"Hospital and health-system pharmacy leaders should expect to continue suffering from drug expenditure whiplash in 2021 and beyond as they manage the implications from COVID-19, including the commercial availability of new high-cost drug therapies and shifts in site of care throughout the evolution of the pandemic,” Tichy said in a press release.

As drugs approved under emergency use authorizations transition to full FDA approval, expenditures for agents like remdesivir and monoclonal antibody cocktails will move from the federal government to the sectors where care is delivered, according to ASHP.“Remdesivir exceeded expenditures for all drugs in nonfederal hospitals, despite it only being commercially available for the final three months of 2020,” ASHP said.

Approvals for several new drugs for the management of COVID-19 will impact spending in coming years, the report predicts.

FDA issues new warning on Pfizer’s Xeljanz

Hospitals and health systems are also likely to see a rebound of prescription drug expenditures resulting from higher utilization of acute care services due to patients' reluctance to get preventative care during the pandemic.

The report also predicts the expanded use of biosimilars over innovator products will serve as a powerful deflationary force on drug expenditures for the foreseeable future. Expected approvals of new biosimilars for adalimumab (Humira, other brand names), ranibizumab (Lucentis), and pegfilgrastim (Neulasta) in 2021 and 2022 will increase competition and may cause further reductions in expenditures, ASHP said.

Other factors expected to influence prescription drug spending in 2021 include a large pipeline of new cancer drugs, the development of treatments for rare diseases, and expected FDA approval of several specialty drugs.

“The growth in spending on specialty drugs continues to outpace the rest of the market and could exceed 50% of overall drug expenditures in 2021,” ASHP said. Efforts by payers to implement site-of-care restrictions will push more use of high-cost specialty drugs out of hospitals and into lower-cost sites, including ambulatory infusion centers and homecare, the report predicts.

Axsome Therapeutics’ antidepressant drug could become blockbuster

The pandemic is expected to have a significant effect on drug costs this year and into 2022, a new report says.

COVID-19 pushes up prescription drug spending of healthcare systems 

An analyst is predicting that Axsome Therapeutics’ novel antidepressant therapy, which was granted Priority Review by FDA on April 26, will become a blockbuster drug.

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist with multimodal activity to treat major depressive disorder (MDD), Axsome said in a 

“In clinical trials, AXS-05 has demonstrated rapid and sustained anti-depressive effects, which will enable it to meet some of the key unmet needs that exist in the major depressive disorder (MDD) market for more effective therapies, as well as for therapies with a rapid onset of action,” said Philippa Salter, neurology analyst for GlobalData in a press release. As a result, GlobalData expects “strong uptake” of AXS-05 when it reaches the market.

FDA previously granted Breakthrough Therapy Designation for AXS-05 for the treatment of MDD in March 2019. The FDA also granted Breakthrough Therapy Designation for AXS-05 for a second indication, Alzheimer’s disease agitation, in June 2020.

Controversial nasal depression spray snares new indication

Axsome’s new drug application for AXS-05 is supported by results from two randomized, double-blind, controlled trials of AXS-05 in patients with a confirmed diagnosis of moderate to severe MDD, which demonstrated statistically significant improvements in depressive symptoms with AXS-05 compared to placebo and active controls, respectively, Axsome said.

AXS-05 will have the potential to become a blockbuster drug by 2026 and will boast global sales of around $1.3 billion by 2029, data and analytics firm GlobalData predicts.

However, AXS-05 is unlikely to become a first-line therapy for MDD, according to Salter. “The current first-line therapies, such as the selective serotonin reuptake inhibitors (SSRIs) and the serotonin-norepinephrine reuptake inhibitor (SNRIs), are very well entrenched in the market and have the advantage of being available as cheap generics, making it challenging for new, more expensive therapies to compete.”

The major depressive disorder (MDD) market is expected to grow from $3.97 billion in 2019 to $7.87 billion by 2029 across eight major markets — US, France, Germany, Italy, Spain, UK, Japan, and Canada — GlobalData said in a separate report, 

Major Depressive Disorder – Global Drug Forecast and Market Analysis to 2029

The main driver of growth will be the launch of eight new pipeline products throughout the eight major markets, GlobalData said.

Breakthrough nasal spray for depression not without risks

The major depressive disorder (MDD) market is expected to soar to $7.87 billion by 2029.

Axsome Therapeutics antidepressant drug could become blockbuster

FDA approved Bristol-Myers Squibb’s Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer. There are 21 indications for the drug across 12 types of cancer.

New Cabometyx-Opdivo combination for renal cell carcinoma treatment

“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a 

There are approximately 28,000 new diagnoses of gastric cancer each year in the U.S. and with currently available therapy, overall survival is generally poor, FDA said. The survival rate for all stages is 32%, and the 5-year survival rate for advanced or metastatic gastric cancer is only 5%.

FDA’s approval was based on a randomized, multicenter, open-label trial of 1,581 patients with previously untreated advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma.

The median survival was 13.8 months for patients who received Opdivo plus chemotherapy compared to 11.6 months for patients who received chemotherapy alone.

FDA clears Orgovyx, the first-of-its-kind prostate cancer treatment

In an exploratory analysis of all patients, 55% of patients on Opdivo in combination with chemotherapy were alive at one year versus 48% of patients on chemotherapy alone, BMS said in a 

The most common side effects of Opdivo in combination with chemotherapy include peripheral neuropathy (damage to the nerves outside of the brain and spinal cord), nausea, fatigue, diarrhea, vomiting, decreased appetite, abdominal pain, constipation and musculoskeletal pain.

Opdivo can cause immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands, and kidneys.

FDA fast-tracks investigational leukemia treatment

Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

OptumRx is the latest major commercial plan to add the corticosteroid loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis, Kala Pharmaceuticals) to its formulary, effective May 21, 2021. More than 88 million people with commercial health insurance now have access to the therapy, Todd Bazemore, chief operating officer of Kala, said in a company 

“We anticipate this figure will continue to grow from our ongoing efforts with commercial and Medicare Part D health plans, as we work toward our goal of delivering broad payer coverage for Eysuvis to the millions of people in the United States who suffer from dry eye disease,” he said in the statement.

 that Cigna had added Eysuvis as the preferred brand on its commercial formulary, effective May 15, 2021, and Express Scripts 

 the therapy to its formulary effective February 5, 2021.

 for the short-term treatment of dry eye disease based on the results of three phase 3 trials and one phase 2 trial. Statistical significance was seen in two of the phase 3 trials with the endpoint of ocular discomfort in both the intent-to-treat population and a subgroup of patients with severe ocular symptoms.

The most common adverse event seen was site pain, which was reported in 5% of patients. The therapy uses Kala’s AMPPLIFY MPP drug delivery technology to enhance penetration of loteprednol etabonate in the eye. The therapy is contraindicated in viral diseases of the cornea, including epithelial herpes simplex keratitis, vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases.

Eysuvis became available in January 2021. Between early January and April 23, 2021, more than 11,600 prescriptions were filled for Eysuvis.

About 6.8% of the population, or about 16.4 million people, is 

 to have dry eye disease. Prevalence is higher among women than men and increases with age.

Three commercial plans now cover the corticosteroid Eysuvis.

New Dry Eye Therapy Gains Formulary Coverage 

After much controversy and back and forth. FDA finally approved aducanumab (Aduhelm,
Biogen) for patients with Alzheimer’s disease.

In November 2020, FDA advisory committee of outside experts voted against recommending approval of Aduhelm, the first novel therapy approved for Alzheimer’s since 2003. Plus, clinical trial results for the drug have been mixed. At one point, Biogen shelved the drug before re-analyzing trial results and restarting the process for gaining FDA clearance.

The new drug is expected to generate billions of dollars in revenue for Biogen, 

. The Institute for Clinical and Economic Review (ICER)., a not-for-profit organization in Boston that issues reports on drug pricing and value, said in a 

issued in May that the drug, based on the results of two critical clinical trials, should be $2,500 to $8,300 for a year's worth of treatment. A more optimistic appraisal of the drug's efficacy yielded a price range of $11,100 to $23,100 annually, according to ICER's cost-effectiveness math.

Dr. Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, acknowledged the controversy and questions surrounding Aduhelm. “There has been considerable public debate on whether Aduhelm should be approved,” she said in a 

. “The data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit.”

At the same time, Aduhelm’s approval is significant since it is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain, Cavazzoni said.

“The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia,” she said.

“This approval allows people living with Alzheimer’s more time to live better,” Harry Johns, CEO of the Alzheimer’s Association, said in a statement. For families it means being able to hold on to their loved ones longer. It is about reinvigorating scientists and companies in the fight against this scourge of a disease. It is about hope.”

FDA followed its usual course of action “when making regulatory decisions in situations where the data are not straightforward,” Cavazzoni said. “We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data.”

FDA ultimately decided to use the Accelerated Approval pathway, which is intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit, Cavazzoni explained.

“In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” she added.

The late-stage development program for Aduhelm consisted of two phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline, while the second trial did not meet the primary endpoint.

However, in all studies in which it was evaluated, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. “It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline,” Cavazzoni said.

FDA will continue to monitor Aduhelm as it reaches the market and the agency is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. “If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm,” Cavazzoni said.

Today's approval goes against the advice of an outside advisory committee.

FDA Greenlights Controversial Aducanumab, Biogen's Alzheimer’s Treatment

Semaglutide injection (Wegovy, Novo Nordisk), a 2.4 mg once-weekly injection, is for chronic weight management in adults with obesity or overweight with at least one weight-related condition.

Novo Nordisk seeks weight loss indication for Ozempic

The weight loss drug will be available later in June. Novo Nordisk’s semaglutide 1 mg injection (Ozempic) was first approved to treat type 2 diabetes in 2017.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a 

Around 70% of American adults have obesity or overweight, according to FDA.

Wegovy’s safety and efficacy were studied in four 68-week trials. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%sustained over 68 weeks was in patients treated with Wegovy, Novo Nordisk said in a 

In another trial of adults with type 2 diabetes, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.

Pharma maker pulls weight loss drug over FDA concerns

Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.

The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the potential risk of thyroid C-cell tumors. Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), FDA said.

The medication also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye's retina), increased heart rate and suicidal behavior or thinking.]

Semaglutide injection is a weekly injection for chronic weight management in adults.

FDA clears first chronic weight loss drug in 7 years

The cost of healthcare is the biggest issue healthcare leaders face, a new survey says. Plus, communication between prescribers and pharmacists is the top concern in medication management.

Around 49% of the more than 300 healthcare providers, hospital/health system executives, 

, advocacy groups, and academics surveyed by Get the Medications Right™ (GTMRx) Institute said the cost of healthcare is the biggest issue they face.

Similarly, a separate report, the American Society of Health-System Pharmacists’ (ASHP) 

 found costs related to the pandemic will continue to be a significant driver of healthcare systems’ drug expenditures in 2021, along with uptake in the use of biosimilars, a large pipeline of new cancer drugs, and increased approvals of specialty medications.

IN the GTMRx survey, 27% said that personal silos preventing integrated patient-centered care is the biggest healthcare issue, while 16.5% named access to healthcare and 7% said appropriately managing medications.

Fifty percent said lack of communication is the biggest issue in medication management, while 36% said the cost of medications is the top concern, and nearly 13% called out a “trial and error” approach to prescribing as the biggest concern.

Around 49% of the more than 300 healthcare providers, hospital/health system executives, payers, advocacy groups, and academics surveyed by Get the Medications Right™ (GTMRx) Institute said the cost of healthcare is the biggest issue they face.

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