Some Blues Say They Won't Cover Aduhelm, as FDA's Acting Chief Calls for Investigation

Alzheimer's Coverage Denied

 Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]), in the United States. The therapy is for the treatment of patients 6 years and older with attention deficit hyperactivity disorder (ADHD).

"The launch of Azstarys provides patients with ADHD, their caregivers, and their clinicians with a first-of-its-kind treatment that offers both rapid and extended ADHD symptom improvement because of the dual action of its formulation using the prodrug SDX with IR MPH," Perry J. Sternberg, president and chief executive officer of Corium, said in a statement.

 Azstarys in March 2021. It is the first and only product containing SDX, an extended-release oral prodrug of d-MPH. It is available in three once-daily dosage strengths of SDX/d-MPH: 26.1/5.2 mg, 39.2/7.8 mg, and 52.3/10.4 mg. The therapy is classified by the U.S. Drug Enforcement Administration as a Schedule II therapy.

After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day. It is designed to provide symptom control rapidly with the d-MPH and for an extended duration with SDX.

Company officials say this dual action addresses the unmet needs in the market, including early onset of action and long duration of therapy, with steady ADHD symptom control.

Azstarys was evaluated in a multicenter, double-blind, randomized, placebo-controlled, laboratory classroom phase 3 study in 150 children aged 6 to 12 years diagnosed with ADHD. The results of this study were presented in January 2021 at the American Professional Society of ADHD and Related Disorders Annual Meeting.

As of 2016, 6.1 million children aged 2-17 years living in the U.S. had been diagnosed ADHD, 

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Azstarys is approved to treat patients 6 years and older.

New ADHD Treatment is Now Available

The benefits of the COVID-19 vaccine outweigh the low risk of developing myocarditis after receiving it, according to new research.

Last month, the U.S. Centers for Disease Control and Prevention (CDC) identified a likely association between the two COVID-19 mRNA vaccines from Pfizer-BioNTech and Moderna, and cases of suspected myocarditis and pericarditis, the American Heart Association noted in a 

Most of the suspected cases of myocarditis developed after the second dose of a COVID-19 vaccine and were among younger males between the ages of 12 and 39 years old.

According to the new study, published on July 20 in the American Heart Association’s journal 

, the rates of suspected myocarditis/pericarditis were about 12.6 cases per million doses of the second dose of a COVID-19 mRNA vaccine among 12 to 39 year-olds as of June 5, 2021.

The researchers also conducted a prevention analysis by comparing the rate of suspected myocarditis to the prevention of COVID-19, COVID-19-associated hospitalization, COVID-19 ICU admission and COVID-19-related death.

There is a known potential risk of complications with COVID-19 infection, including hospitalizations and death, even in younger adults, and mortality remains 0.1-1 per 100,000 for people 12 to 29 years old, the researchers said.

The risk-benefit decision remains overwhelmingly favorable for vaccination, the researchers wrote and is recommended for everyone 12 years of age and older.

“COVID-19 vaccination not only prevents COVID-19-related hospitalizations and death, but also COVID-19 related complications such as myocarditis, multisystem inflammatory syndrome (MIS) and post-acute sequelae (i.e., consequences) of SARS-CoV-2 infection or long COVID-19,” the researchers wrote.

Still, the potential for myocarditis and pericarditis should be considered in individuals presenting with chest pain within a week after receiving a COVID-19 vaccine, especially among adolescents, teens, and young adults.

Researchers conducted an analysis of data from the CDC’s Vaccine Adverse Event Reporting System (VAERS) and from multiple peer-reviewed scientific journal articles to compare vaccination rates to reports of myocarditis among people who received the COVID-19 vaccine through mid-June 2021.

They also found that most people suspected to have myocarditis presented with chest pain, usually two to three days after a second dose of a COVID-19 mRNA vaccination. Those affected and requiring hospitalization for suspected myocarditis were mostly young males (12 to 19 years old) without a prior history of COVID-19 or other health conditions.

Most patients were discharged from the hospital as their symptoms, diagnostic and imaging signs of the condition returned to normal, either with or without treatment.

Most of the suspected cases of myocarditis developed after the second dose of the vaccine and were among younger males.

COVID-19 Vaccine Benefits Outweigh Low Risk of Developing Myocarditis, Study Finds

 the commercial availability in the United States of Wynzora Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) for the topical treatment of plaque psoriasis in adults 18 years of age or older.

Wynzora is a cream-based, fixed-dose combination of calcipotriene and betamethasone dipropionate. It uses the PAD Technology, which enables stability of both calcipotriene and betamethasone dipropionate in a aqueous formulation and works to clear plaques without the messiness of conventional formulations.

“Calcipotriene and betamethasone dipropionate are well-established molecules for the treatment of plaque psoriasis, with proven efficacy, safety and tolerability. Until now they could not be combined into an aqueous cream, which is less greasy and more user-friendly than other formulations,” John Koo, M.D., professor of dermatology at University of California San Francisco medical center and co-director, UCSF Psoriasis Treatment Center, said in a statement.

, psoriasis affects more than 3% of the U.S. adult population, or 7.5 million people. One in three of these will develop psoriatic arthritis, a chronic, inflammatory disease of the joints and where tendons and ligaments connect to bone.

Wynzora is a cream-based, fixed dose combination of calcipotriene and betamethasone for topical treatment of psoriasis.

Plaque Psoriasis Treatment is Launched

Apotex Corp., in coordination with the FDA, has 

 temporary importation of Apo-Varenicline (varenicline tartrate) 0.5 mg and 1 mg tablets into the U.S. market to address a drug shortage related to the recall of Chantix (varenicline), Pfizer's smoking cessation product. Apo-Varenicline is the varenicline tartrate product approved by Health Canada as a generic equivalent to Champix tablets manufactured by Pfizer Canada. Champix is the brand name of Chantix in Canada.

In July 2021, Pfizer stopped distribution and initiated Chantix because of high levels of nitrosamine impurity, called N-nitroso-varenicline. N-nitroso-varenicline may be associated with a potential increased cancer risk in humans. On Monday, Pfizer 

The regulatory agency said, however, that there was no immediate risk to cancer patients, and that increased cancer risk would be associated with long-term use of Chantix.

The FDA announced on Friday, July 16, that it would allow an interim limit of 185 ng per milliliter a day until the impurity can be eliminated or reduced.

According to an FDA spokesperson, this is not related to the 

, which became effective November 30, 2020.

In this case, the FDA exercised regulatory flexibility and discretion to address drug shortages and mitigate any significant risk to patients. 

"FDA evaluates the needs of the market and specific situations to determine when to exercise this type of discretion under controlled circumstances," the spokesperson said in an email. "In certain shortage situations, the temporary exercise of regulatory flexibility and discretion has proven to be an important tool in helping to alleviate a drug shortage and to ensure access to treatment options for patients in critical need."

This is being done in coordination with the FDA to address the shortage created by the recall of Chantix. UPDATE: Pfizer has expanded its recall of Chantix from nine lots to 12 lots.

Apotex to Import Generic of Chantix from Canada

The FDA has found deficiencies in Ardelyx’s NDA for tenapanor, a first-in-class oral therapy for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis, according to an

 from the company. The deficiencies are related to the size of the treatment effect and its clinical relevance.

“Our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA's requests,” Mike Raab, president and chief executive officer of Ardelyx, said in a statement. "We plan to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible."

 the PDUFA review period for tenapanor to July 29, 2021. The agency had requested the company to submit additional analyses in light of tenapanor’s novel mechanism of action. Ardelyx has submitted its NDA in June 2020.

 is expecting the FDA to issue a Complete Response Letter, and the company’s stock began 

 on Tuesday. “From the sound of things, the agency doesn't plan on approving the drug during this review cycle. The FDA, in fact, refused to even meet with Ardelyx to discuss the NDA's areas of concern,” according to analysts with Motley Fool.

About 80% of patients with chronic kidney disease who are on dialysis require phosphate-lowering therapy. 

, an electrolyte disorder in which there is an elevated level of phosphate in the blood, is a major risk factor for cardiovascular morbidity and mortality in patients on dialysis.

The company’s stock began dropping on Tuesday with analyst expectation the FDA will issue a Complete Response Letter for tenapanor, its chronic kidney disease therapy.

Ardelyx’s Regulatory Update Suggests NDA Approval is in Jeopardy 

OptumRx, part of the UnitedHealth Group, has 

 RedHill Biopharma’s Talicia (omeprazole magnesium, amoxicillin and rifabutin) to its commercial formulary as an unrestricted brand for 

This decision extends U.S. health care coverage for Talica to more than 26 million Americans, according to officials from RedHill. “This listing represents the understanding within the medical community of the need to combat the high and growing resistance of

 to commonly used antibiotics with an effective new first-line treatment,” Rick Scruggs, RedHill’s chief commercial officer, said in a statement.

Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, the FDA 

 infection in adults. In the pivotal phase 3 study, Talicia demonstrated 84% eradication of 

 infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm. This study also showed that patients in the trial who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm.

 infection can lead to increased risk of stomach cancer, 

 to the World Health Organization. Stomach cancer is the fourth most common cancer worldwide and the second most common cause of cancer death globally, 

Eight out of 10 covered U.S. commercial lives now have access to the H. pylori therapy.

OptumRx has Added Talicia to its Commercial Formulary

Cholesterol-lowering or statin medications were associated with more than a 40% reduction in deaths in hospitalized COVID-19 patients, new research finds.

, University of California-San Diego researchers used data from more than 10,500 patients hospitalized with COVID-19 through September 2020 at 104 U.S. hospitals enrolled in the American Heart Association’s COVID-19 Cardiovascular Disease (CVD) Registry. The objective was to evaluated the associations between statin use and outcomes.

Prior to admission, 42% of the patients used statins. Seven percent were on statins alone, while 35% were taking statins plus anti-hypertensives.

Sixty-six percent of patients had a history of hypertension, 41% of patients were obese, 40% had diabetes, 40% had dyslipidemia, and 32% had CVD. Other comorbid conditions with 5% or greater prevalence included pulmonary disease (18%), chronic kidney disease (15%), cancer (12%) and history of smoking/vaping (7%).

Among the 3,360 CVD patients, 83% also had a history of hypertension.

Overall, 21% of patients died. However, statins were associated with a more than 40% reduction in in-hospital death, and a greater than 25% reduction in the risk of developing a severe outcome, AHA said in a 

“To our knowledge, this is the first analysis to investigate the effect of statins on COVID-19 outcomes in a ‘healthy’ population without underlying CVD or hypertension,” the researchers wrote. “Although the effect of statins in this healthier population was not statistically significant, the point estimates of the odds ratios suggest that statins could still be protective.”

Early in the pandemic, there were questions as to whether certain cardiovascular medications might worsen COVID-19 infections, according to Lori Daniels, M.D., MAS, lead author of the study and professor and director of the Cardiovascular Intensive Care Unit at UC San Diego Health.

“We found that not only are statins and anti-hypertensive medications safe, they may very well be protective in patients hospitalized for COVID, especially among those with a history of hypertension or cardiovascular disease,” Daniels said in the AHA statement.

The results support the “continuation and aggressive initiation of statin and anti-hypertensive therapies among patients at risk for COVID-19, if these treatments are indicated based upon underlying medical conditions,” AHA noted.

This research sought to understand the relationship of prior medication exposure, existing health conditions, and COVID-19 outcomes using data from the American Heart Association’s COVID-19 Cardiovascular Disease Registry.

Study: Statins Reduce Death Rate in Patients with COVID-19

 the FDA has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine), a vaccine to prevent pneumococcal disease in adults 18 years of age and older. The vaccine provides immunization for the prevention of invasive disease caused by several serotypes of 

The approval was based on data from seven randomized, double-blind clinical studies assessing safety, tolerability, and immunogenicity in adults. Clinical data showed that immune responses elicited by Vaxneuvance were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes.

Vaxneuvance is administered as a single dose via intramuscular injection. Common adverse reactions include pain at the injection site, fatigue, muscle pain, headache, redness and swelling at the injection site, and arthralgia.

“The FDA approval of Vaxneuvance builds on Merck’s more than 40 years of experience in pneumococcal disease prevention with a new option that includes serotypes responsible for substantial disease burden in adults, like serotype 3, as well as serotypes 22F and 33F, which are associated with a high degree of invasiveness and antibiotic resistance,” Roy Baynes, MB BCH, Ph.D., senior vice president and head of global clinical development, chief medical officer, at Merck Research Laboratories, said in a statement.

In January 2021, Vaxneuvance received Priority Review designation.

 Vaxneuvance is approved for 15 serotypes, including those that are major causes of disease.

FDA Approves Merck's Vaccine for Pneumococcal Disease

Current drug shortages based on FDA data, prepared by Formulary Watch.

Formulary Watch: Drug Shortages, July 18, 2021

 On Thursday, the FDA Cardiovascular and Renal Drugs Advisory Committee 

 recommending approval for roxadustat for anemia in patients with chronic kidney disease (CKD). Panelists cited safety issues in two votes against approval: 12-2 in patients who are on dialysis and 13-1 in patients who not on dialysis. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is being developed to treat anemia in patients with CKD. HIF-PHI drugs aim to restore production of the hormone erythropoietin and improve iron regulation; currently, the condition is treated by injections of epoetin alpha and darbepoetin alpha. Enrique Conterno, chief executive officer of FibroGen, the drug’s sponsor, pledged to continue to work with the FDA. FibroGen is developing the drug with AstraZeneca.

More missed PDUFA dates in JAK inhibitors.

 Early Friday, manufacturers of two JAK inhibitors announced that FDA decisions on their supplemental New Drug Applications (sNDAs) would not be made by deadlines under the Prescription Drug User Fee Act (PDUFA). In both cases, companies are awaiting decisions on JAK inhibitors that would treat atopic dermatitis. AbbVie 

 on Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis; last month, the company announced a delay in the FDA review of requested indications in active psoriatic arthritis and for adults with ankylosing spondylitis. Eli Lilly and Company and Incyte 

 on Olumiant (baricitinib) for the treatment of adults with moderate to severe atopic dermatitis (AD). Both drugs have been approved for other indications. The review is related to FDA’s ongoing review of JAK inhibitors, after a post-marketing study of Pfizer’s JAK inhibitor Xeljanz in patients with rheumatoid arthritis triggered a 

 warning of higher risks of cancer and a higher occurrence of serious heart-related events.

Bayer approval in CKD with type 2 diabetes.

 FDA approval as a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) for CKD in patients with type 2 diabetes. The drug is approved to cut the risk of eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction and hospitalization for heart failure in adult patients with CKD associated with type 2 diabetes, also known as diabetic kidney disease. Approval is based on the FIDELIO-DKD study.

Treatment for chronic Graft vs Host Disease. 

Rezurock will be available in late August, following FDA 

 after a previous delay. Rezurock (belumodusil) is the first small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. Approval comes after a trial of 65 patients who had two to five prior lines of systemic therapy for cGVHD; those taking the study therapy had an overall response rate of 75% through cycle 7 day 1 of treatment, with 6% of patients achieving a complete response and 69% achieving a partial response. Sixty-two percent (62%) of responders did not require new systemic therapy for at least 12 months following response.

FDA staff raised safety concerns ahead of the advisory panel hearing.

FDA Panel Hearing on Roxadustat Leads the Week

It takes nearly three years before first generics are covered on more than half of Medicare Part D formularies, according to a 

 by the Association for Accessible Medicines. In 2020, 72 first generics were approved. They typically enter the market at a discount between 40% to 60%.

On average, of the first generics launched in 2020, only 21% are covered by plan formularies in Medicare Part D plans. When first generics were covered, they were placed on non-generic tiers 79% of the time. In comparison, an average of 66% of commercial plans are covering first generics launched in 2020. Of those plans that cover first generics, 98% place them on generic tiers.

“There are structural elements of the Medicare drug program that unintentionally are causing plans to devalue or undervalue generics in the Medicare program compared to how they value them in commercial health care settings,” Craig Burton, vice president of policy at Association for Accessible Medicines, said in an interview with Formulary Watch®. “This means that seniors in Medicare are facing delayed access to lower costs drugs. As a result, it means they are paying more. It means their out-of-pocket costs are higher because the out-of-pocket cost is based on the list price. And when the only drug that is covered is the brand, their co-insurance is going to be higher.”

Burton noted the use of generics instead of branded products means lower costs overall and lower costs for seniors. He cited a 2019 report by the FDA, which found greater competition among generic drug makers is associated with lower generic prices.

Additionally, branded dispensing incurred an incremental annual cost of $1.67 billion to the Medicare program and $270 million to patients when compared with switching to generics, according to a 

This study examined data from January 2020 through October 2020. Among 169 million claims for 224 multisource drugs, 8.3 million claims (4.9%) were dispensed with a branded product. If all branded dispensing requested by prescribers had been substituted by the corresponding generics, the projected savings to the Medicare Part D program would have been $997 million (56.0%) and to Medicare patients $161 million (64.4%).

When Medicare D plans do provide coverage for first generics, they are often placed on non-generic tiers.

Medicare Part D Plans are Slower to Cover First Generics

 that the National Comprehensive Cancer Network (NCCN) added Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to the Clinical Practice Guidelines in Oncology for acute lymphoblastic leukemia (ALL), for both pediatric and adult patients.

 Rylaze on July 21, just three weeks after the drug was approved by the FDA. The approval followed review of a biologics license application (BLA) under the FDA’s Real-Time Oncology Review program, and it was based on clinical data from a pivotal phase 2/3 trial conducted in collaboration with the Children’s Oncology Group.

“Asparaginase is a core component of chemotherapeutic regimens in ALL and lymphoblastic lymphoma; however, treatments derived from 

 are associated with the potential for hypersensitivity reactions, which can affect a substantial number of these patients,” Rob Iannone, M.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals, said in a statement. “Before the FDA approval of Rylaze, there was a significant need for an effective and reliable supply of asparaginase medicine that would allow patients the opportunity to start and complete their prescribed treatment program with confidence.”

The only other FDA-approved drug for such patients with allergic reactions has been under global shortage since 2016. Jazz Pharmaceuticals’ Erwinaze (asparaginase erwinia chrysanthemi) has 

 supply and manufacturing issues from the owner and manufacturer of the product, Porton Biopharma Limited. Jazz Pharmaceuticals’ agreement with Porton Biopharma ended in December 2020.

The June 30 approval meets an unmet need in this cancer.

NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines

 reaccreditation from URAC for its mail service pharmacy services. URAC is an independent organization focused on promoting healthcare quality through leadership, accreditation, measurement, and innovation. The reaccreditation is effective from July 1, 2021, to July 1, 2024.

Formed in 2017 through a collaboration between Walgreens and Prime Therapeutics, AllianceRx Walgreens Prime is a specialty pharmacy that manages prescriptions for complex, chronic, and rare diseases and conditions. The company is headquartered in Orlando, Fla.

As a specialty pharmacy, AllianceRx Walgreens Prime also helps to connect patients with financial assistance. Over the last two years, the company has 

 eligible patients to more than $600 million in financial assistance. The Patient Financial Services team works with patients to identify financial concerns and match them with the appropriate available resources. Resources will vary based on prescribed therapy, diagnosis and prescription drug coverage.

“At AllianceRx Walgreens Prime, we are able to connect eligible patients with such financial resources as co-pay assistance, manufacturer voucher and bridge programs, government subsidies, community and state resources, assistance from disease-specific foundations, and SDOH (social determinants of health) programs,” Lisa Mymo, vice president, Pharma and Financial Services, said in an email. “Through our collaboration with TailorMed, we also have real-time access to information regarding the status of over 5,000 available programs. Improving access to these vital, yet expensive therapies, means our patients are more likely to adhere to treatment and better manage their rare disease or chronic conditions.”

The accreditation is effective through July 2024.

AllianceRx Walgreens Prime Home Delivery Earns Reaccreditation

 Onco360 as the pharmacy provider for Rezurock (belumosudil). Onco360 in Louisville, K.Y., is a provider of oncology pharmacy services and dispenses nationally through its network of URAC-, ACHC-, and NABP digital-accredited pharmacies. It is a specialty pharmacy brand of PharMerica Corporation.

 Rezurock on July 16 for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy.

Rezurock is expected to be available by late August 2021

“As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of chronic GVHD patients,” Benito Fernandez, chief commercial officer, Onco360, said in a statement.

Rezurock is the first FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modulates inflammatory responses and fibrotic processes. The approval is based on safety and efficacy results from ROCKstar (KD025-213), a randomized, open-label, multicenter pivotal trial of Rezurock in 65 patients with cGVHD who had received two to five prior lines of systemic therapy.

The therapy achieved an overall response rate of 75% through cycle 7 day 1 of treatment with 6% of patients achieving a complete response and 69% achieving a partial response. Sixty-two percent (62%) of responders did not require new systemic therapy for at least 12 months following response.

The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.

Onco360 Chosen as Pharmacy Provider for Rezurock 

 Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn). The FDA 

 Rylaze on June 30, 2021, as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to 

Rylaze was licensed from Ligand Pharmaceuticals.

The only other FDA-approved drug for such patients with allergic reactions has been under global shortage since 2016. Jazz Pharmaceuticals’ Erwinaze (asparaginase erwinia chrysanthemi) has experienced supply and manufacturing issues from the owner and manufacturer of the product, Porton Biopharma Limited. Jazz Pharmaceuticals’ 

 with Porton Biopharma ended in December 2020.

In May 2021, the FDA had authorized Porton Biopharma and its distributor Clinigen to import Erwinase (crisantaspase) into the United States and 

Jazz licensed Rylaze from Ligand Pharmaceuticals, which received a $2 million payment when the FDA accepted the BLA for review and is entitled to receive a $5 million payment upon the first commercial sale following launch.

The therapy is approved for both adults and children.

Medicare Part D Plans are Slower to Cover First Generics

NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines

AllianceRx Walgreens Prime Home Delivery Earns Reaccreditation

Onco360 Chosen as Pharmacy Provider for Rezurock

Jazz Pharmaceuticals Launches ALL Therapy Rylaze