Treatments for the human immunodeficiency virus (HIV) are expected to reach $28 billion in sales in 2029, driven by injectable medications, a recent report says.

The total HIV therapeutics market was worth an estimated $22.9 billion across 7 major markets globally in 2019, according to GlobalData’s ‘

Therapeutics: Global Drug Forecast and Market Analysis to 2029

The 7 markets include the U.S., France, Germany, Italy, Spain, the United Kingdom, and Japan,

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Sales of injectable therapies are expected to exceed $1.8 billion in 2029. Injectables provide a viable alternative to oral medications since patients may not remember to take their medications, said Magdalene Crabbe, MA, senior ophthalmology and infectious diseases analyst at GlobalData, in a 

“The launch of STRs [single-tablet regimens of combination antiretroviral drugs] revolutionized the treatment landscape of HIV and met major unmet needs by increasing patient compliance and improving the safety and tolerability profiles of antiretroviral drugs,” Crabbe said.

However, there are challenges with STRs, according to Crabbe. “A key component of multiple drugs is tenofovir disoproxil fumarate (TDF), which has been linked to osteoporosis and kidney disease. There are also people who don’t remember to take their medication, and people who feel embarrassed about living with HIV, which lowers compliance,” she said.

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Roche’s Fuzeon (enfuvirtide) was the first subcutaneously-administrable drug to be approved for the treatment of HIV-infected patients. “However, the fact that the drug is administered multiple times daily has led to difficulties with adherence and the emergence of injection-site related adverse events such as lipohypertrophy, erythema and pruritus,” GlobalData said.

By 2029, other injectable therapies such as CytoDyn’s leronlimab and Gilead Sciences’ Lenacapavir will be available in the market, according to Crabbe.

In addition, TaiMed’s Trogarzo (ibalizumab), which is an intravenously administered monoclonal antibody, launched in the U.S. in 2018 and in Europe in 2020.

There is also an increased market for HIV treatments due to the increase in cases of the disease. GlobalData projects that the diagnosed prevalent HIV cases in the seven major markets will increase from 1.87 million in 2019 to 2.1 million in 2029.

The U.S. will have the highest number of diagnosed prevalent cases of HIV in 2029 with more than 1.4 million, according to GlobalData’s report, 

Human Immunodeficiency Virus (HIV): Epidemiology Forecast to 2029

Gilead snags approval for second HIV-1 prevention drug

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Injectables are driving the growth because they can be taken less frequently and adherence is a problem with oral medications.


 HIV therapeutics market to reach $28 billion in 2029

FDA’s approval of a broader indication  for sacubitril/valsartan (Entresto, Novartis) is expected to generate signficant additional sales of the drug that netted $1.7 billion in sales last year.

FDA approved the expanded indication to reduce the risk of cardiovascular death and hospitalization in a specific type of heart failure. The benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal, Novartis said in a 

Blockbuster diabetes drug snags new heart indication

Entresto is already approved to treat heart failure with reduced ejection fraction (HFrEF).

“For the first time, there is a treatment with benefit for patients diagnosed with guideline-defined heart failure that includes both those with heart failure with reduced ejection fraction (HFrEF) and many with heart failure with preserved ejection fraction (HFpEF)1-3,” Novartis said.

Many heart failure patients were not previously eligible for treatment before because “their ejection fraction was above the region we normally considered reduced,” said Scott Solomon, MD, professor of medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “We can now offer a treatment to a wider range of patients who have an LVEF below normal.”

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The label expansion is based on efficacy and safety results from the PARAGON-HF, which Novartis says is the largest and only Phase 3 active-controlled study to date in patients with guideline-defined HFpEF2,5,6.

In the trial, the greatest benefit was shown in patients with LVEF below normal, Novartis said.

Around 6 million Americans are living with chronic heart failure (CHF). Approximately 3 million have HFrEF, and of the remaining 3 million, about 2 million have HFpEF with LVEF below normal, according to Novartis.

The expanded indication is important because CHF patients often face worsening symptoms that result in frequent heart failure hospitalizations and approximately 1 in 4 patients are re-admitted for heart failure. In addition, 10% may die within 30 days of discharge, Novartis said.

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

The FDA approved the use of Entresto in a broader group of heart failure patients that includes a large percentage of those with preserved ejection fraction. 

Blockbuster heart drug Entresto gets expanded indication

Novo Nordisk has asked the FDA to expand the indication for its type 2 diabetes drug semaglutide (Ozempic) after a study sponsored by the company showed significant weight loss in patients without diabetes.

Overweight and obese people taking Ozempic had a “sustained, clinical relevant reduction in body weight,” according to the doule-blind, placebo-controlled

 published in the Feb. 10, 2021, issue of the 

The results from that study are the basis for the company’s application for the expanded indication for Ozempic.

Semaglutide is an glucagon-like peptide-1 (GLP-1) agonist. Other drugs in that class include dulaglutide (Trulicity), liraglutide (Victoza) and exenatide (Byettta).

, the injection of 2.4 mg of semaglutide once weekly plus lifestyle intervention resulted in a mean loss in body weight of 14.9% from baseline in the study volunteers who were treated with semaglutide group compared with a 2.4% loss of body weight among those who were treated with a placebo.

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The study included nearly 2,000 adults who had tried to lose weight by changing their diets and either had a BMI of 30 or greater (the standard definition of obesity or a BMI of 27 or greater with one or more treated or untreated weight-related conditions, such as high blood pressure, high LDL cholesterol level or obstructive sleep apnea

“Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease ,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk, in a 

. "We are excited about the regulatory filing of semaglutide 2.4 mg in the U.S. and we believe once-weekly semaglutide 2.4 mg has the potential to transform the medical management of obesity."

More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (86.4% vs. 31.5%), 10% or more (69.1% vs. 12%), and 15% or more (50.5% vs. 4.9%) at week 68 (P<0.001 for all three comparisons of odds).

Participants who received semaglutide had a greater improvement in cardiometabolic risk factors and a greater increase in participant-reported physical functioning from baseline than those who received placebo.

Nausea and diarrhea were the most common adverse events associated with semaglutide, but they were typically transient and mild-to-moderate in severity, according to the authors.

More participants in the semaglutide group than in the placebo group discontinued treatment due to gastrointestinal events (4.5% vs. 0.8%).

Application to the FDA is based on results from a placebo-controlled trial showing a 15% decrease in body weight among those who are obese or overweight.





Novo Nordisk seeks weight-loss indication for Ozempic

The FDA granted emergency authorization to a new monoclonal antibody COVID-19 treatment and millions of additional doses of COVID-19 vaccines will be available this year.

President Joe Biden said last week that his administration had finalized deals for an additional 100 million doses of the Pfizer-BioNTech and the Moderna’s vaccines — 200 million doses in total—  “giving the country enough vaccine by the end of July to cover every American adult,” 

Today's Bloomberg says that the latest vaccination rate is 1,699,303 doses per day. At that rate, it will take eight months to cover 75% of the population with a two-dose vaccine, according to Bloomberg's calculations. 

However, Johnson & Johnson has applied for an emergency use authorization (EUA_ of its single-dose vaccine. if the single-dose vaccine gets an FDA OK (as it is expected to do) then the proportion of vaccinated Americans could increase faster.

The doses that Biden spoke of last week won’t be immediately available, but they will serve to prevent a shortfall later in the year by increasing supply by 50%, the 

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Meanwhile, FDA an issued an EUA on Feb. 9 for Eli Lilly's monoclonal antibody combination, bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016).

The agency's go-ahead is  for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations, said Daniel Skovronsky, MD, PhD, Lilly's chief scientific officer and president of Lilly Research Laboratories, in a 

. “We are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit.”

With the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as the new strains spread around the world, Skovronsky added.

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The EUA is based on Phase 3 data from the BLAZE-1 trial, which demonstrated bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

Bamlanivimab and etesevimab are administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset, according to Lilly.

In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes, according to the pharma maker.

“This decision has been made in response to feedback received from front-line nurses and doctors administering these infusions and are aimed at reducing the burden on the healthcare system,” Lilly said.

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The FDA has approved trilaciclib (Cosela, G1 Therapeutics) as the first therapy in its class to protect bone marrow in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting the enzyme cyclin-dependent kinase 4/6, drug approval agency  said in a 

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“For patients with extensive-stage small cell lung cancer, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan,” said Albert Deisseroth, M.D., Ph.D., supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research.

Cosela is expected to be commercially available through G1’s specialty distributor partner network in early March, according to a 

 issued by the drug's marker, G1 Therapeutics in Research Triangle Park, North Carolina.

The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets, said Jeffrey Crawford, M,D., Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute.

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“Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients’ quality of life and may also result in chemotherapy dose reductions and delays,” Crawford said.

Treatment approaches to date have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed, according to Crawford.

Cosela is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy.

“Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” said Jack Bailey, CEO of G1 Therapeutics, said in a press release. “COSELA will help change the chemotherapy experience for people who are battling ES-SCLC (extensive-stage small cell lung cancer." 

The approval of the new treatment is based on data from three randomized, placebo-controlled trials that showed patients receiving Cosela prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia.

The drug also produced a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated Cosela in combination with carboplatin/etoposide (plus or minus the immunotherapy atezolizumab) and topotecan chemotherapy regimens.

FDA OKs Cosela, first-in-class therapy to protect bone marrow after chemotherapy

Gilead Sciences and Merck will co-develop and co-commercialize long-acting HIV treatments, 

The treatments combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a 2-drug regimen.

HIV therapeutics market to reach $28 billion in 2029

There is an increased demand for HIV treatments, due to some HIV antiretrovirals being used to treat COVID-19 globally. The global HIV drugs market is expected to grow nearly 6% annually to reach $34.2 billion in 2023, according to 

Across 7 major global markets, HIV sales are projected to reach $28 billion in sales in 2029, driven by injectable medications, according to 

Islatravir and lenacapavir are both potentially first-in-class medicines in late-stage clinical trials, with significant clinical data generated so far, Merck and Gilead said. “Both medicines have long half-lives and have demonstrated activity at low dosages in clinical studies, which support development as an investigational combination regimen with long-acting formulations, both oral and injectable,” they noted.

Daily, single tablet regimens are available for those with HIV, but options that would allow for less frequent, oral dosing or infrequent injections rather than daily dosing “have the potential to address preference considerations, as well as issues associated with adherence and privacy,” they said.

“This collaboration with Gilead brings together two companies dedicated to the fight against HIV to develop potential new long-acting treatment options, and is an important step forward in our strategy to harness the full potential of islatravir for the treatment of HIV,” said Kenneth C. Frazier, chairman and CEO of Merck.

The first clinical studies of the oral combination are expected to begin in the second half of 2021.

Companies are working on a 2-drug regimen of Gilead's lenacapavir and Merck’s  islatravir.

Gilead, Merck partner up on long-acting HIV treatment

’s tivozanib (Fotivda) to treat adults with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies.

The drugmaker expects the oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor to be available by the end of March.

“We believe in Fotivda’s potential to provide a differentiated treatment option for the growing number of individuals in the U.S. with relapsed or refractory RCC,” said Michael Bailey, president and CEO of AVEO, in a 

With advances in RCC treatment, patients are living longer, increasing the need for proven, well-tolerated treatment options in the relapsed or refractory setting,” said Brian Rini, MD, chief of clinical rials at the Vanderbilt Ingram Cancer Center and principal investigator of AVEO’s TIVO-3 trial.

AVEO’s TIVO-3 study is the first positive Phase 3 study in RCC patients who received 2 or more prior systemic therapies, and also the first Phase 3 RCC study to include a predefined population of patients who have received prior immunotherapy, the current standard of care in earlier-line treatment, according to Rini.

“With this approval, I believe Fotivda represents an attractive intervention, and expect it to play a meaningful role in the evolving RCC treatment landscape,” Rini said.

In the Phase 3 trial comparing Fotivda or sorafenib (Nexavar, other brands), median progression-free survival (PFS) was 5.6 months in the Fotivda arm versus 3.9 months in those treated with sorafenib. Median overall survival was 16.4 and 19.2 months for the Fotivda and sorafenib arms, respectively.

The objective response rate (ORR) was 18% for the Fotivda arm and 8% for the sorafenib arm.

According to an FDA press release, the most common adverse reactions were fatigue, hypertension, diarrhea, decrease appetite, nausea, dysphonia, hypothyroidism, cough and stomatitis.

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Merck’s experimental antiviral drug showed a quick reduction in SARS-CoV-2 in a phase 2 study.

At day 5, there was a reduction in positive viral culture in subjects who received molnupiravir, an investigational antiviral agent, compared with placebo. None of the 47 study volunteers in the molnupiravir group have positive viral cultures where as six of the 25 (24%) of those in the placebo group did. This finding was a secondary endpoint of the study.

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“The secondary objective findings in this study, of a quicker decrease in infectious virus among individuals with early COVID-19 treated with molnupiravir, are promising,” said William Fischer, the study’s lead investigator and associate professor of medicine at the University of North Carolina School of Medicine, in a 

 from Merck and Ridgeback Biotherapeutics, a biotech start-up in Miami.

Molnupiravir is an oral antiviral agent. The 

 described molnupiravir as “a kind of Tamiflu” for COVID-19.

The preliminary data was presented during the 2021 Conference on Retroviruses and Opportunistic Infections on March 6. Results from the treatment’s Phase 2/3 study are expected in May.

“We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir both outpatient and hospital settings and plan to provide updates when appropriate,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

This multi-center Phase 2a study included 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection.

The primary efficacy objective was reduction in time to viral negativity measured by reverse transcriptase polymerase chain reaction (RT-PCR) analysis of nasopharyngeal swabs.

No safety concerns were identified, according to Merck. Of the four serious adverse events reported, none were considered to be study drug related.

At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data,” said Wendy Painter, chief medical officer of Ridgeback Biotherapeutics.

The still-experimental oral antiviral drug has been compared to Tamiflu but would be for COVID-19 not the flu.

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

One month after AstraZeneca made a similar decision, Roche is voluntarily withdrawing its US indication for atezolizumab (Tecentriq) for prior-platinum treated metastatic urothelial carcinoma (mUC) or bladder cancer.

The decision was made in consultation with FDA as part of an industrywide review of accelerated approvals with confirmatory trials that have not met their primary endpoint and have yet to gain regular approvals, Roche said in a 

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Tecentriq had nearly $3 billion in sales in 2020, Reuters 

 durvalumab’s (Imfinzi) indication for locally advanced or metastatic bladder cancer.

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said 

, M.D., Ph.D., chief medical officer and head of global product development at Roche. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”

FDA's Accelerated Approval Program allows conditional approval of a medication that fills an unmet medical need for a serious condition, with specific post-marketing requirements (PMRs) to confirm the clinical benefit.

FDA granted Tecentriq accelerated approval in 2016 to treat prior-platinum treated mUC based on the results from the IMvigor210 study. Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum treated mUC indication, Roche said.

However, that study did not meet its primary endpoint of overall survival in the PD-L1 high patient population, according to Roche.

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The decision by Roche comes shortly after AstraZeneca withdrew the bladder cancer indication for durvalumab (Imfinzi).

 Roche withdraws bladder cancer indication for blockbuster Tecentriq

FDA approved the supplemental new drug applications (sNDAs) for PLx Pharma’s Vazalore, the first liquid-filled aspirin capsule.

Vazalore is approved by FDA to provide patients with vascular disease  or diabetes who are candidates for aspirin therapy with “fast, reliable and predictable platelet inhibition as compared to enteric-coated aspirin,” PLx Pharma said in a 

. “It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.”

A promotional video on the company website says the liquid-filled capsules are designed to protect the stomach by releasing the aspirin in the duodenum.

Last October, the company submitted separate sNDAs for each dose strength, based on a change in formulation and the new manufacturing site for Vazalore 325 mg along with a new product strength for the 81 mg dose.

PLx Pharma’s sNDA for the 325 mg dose includes the results of a clinical study that demonstrated Vazalore’s bioequivalence to immediate-release aspirin, “further supporting the change in formulation,” the drugmaker said in the press release.  

“We are delighted that the FDA approved both sNDAs for Vazalore and we are eager to implement our commercial launch plans later this year,” said Natasha Giordano, president and CEO of PLx. “We look forward to introducing Vazalore to the medical community and to patients who can benefit from this breakthrough technology designed to reduce the risk of stomach injury."

Novo Nordisk seeks weight loss recommendation for Ozempic

Application was submitted for both the 81 and 325 mg doses of the liquid-filled capsule formulation of aspirin. 