Compensated cirrhosis

Vemlidy is approved to treat patients six years and older for chronic HBV. Credits: Sundry Photography/Shutterstock.com Soon after GSK gained traction with a US Food and Drug Administration (FDA) fast track designation for its investigational treatment bepirovirsen for chronic hepatitis B virus (HBV), Gilead Sciences has strengthened its position in the indication with an FDA approval for Vemlidy (tenofovir alafenamide) to treat paediatric patients. The once daily 25mg tablets have been greenlit to treat patients with chronic HBV with compensated liver disease that are six years and older and weigh at least 25kg. The supplemental new drug application (sNDA) approval was based on data from the ongoing Phase II Study 1092 (NCT02932150), comparing the safety and efficacy of 25mg Vemlidy to placebo in 88 treatment-naïve and treatment-experienced patients with chronic HBV. As per a 28 March press release, patients treated with Vemlidy and those that switched to open-label Vemlidy after week 24 demonstrated “progressive increases in rates of virological suppression” by week 96. “The expanded indication for Vemlidy for the treatment of children as young as six years old is a testament to the safety, tolerability and efficacy profile of this therapy,” said Dr. Frank Duff, Gilead’s senior vice president of the virology therapeutic area, in the announcement. The pharma giant aims to continue addressing unmet treatment needs for children, he added. Vemlidy, a small molecule nucleoside analogue reverse transcriptase inhibitor, was first FDA approved in 2016 as a treatment for adults with chronic HBV and gained its first label expansion in 2022 to treat patients aged 12 years and older with compensated liver disease. The product is marketed with a boxed warning for post-treatment severe acute exacerbation of hepatitis B. See Also: Angelini gets grant for method for labelling reels using robot and application roller Rohto Pharmaceutical gets grant for ophthalmic composition for treating myopia with crocetin and ginkgo leaf GlobalData’s drugs database forecasts that the hepatitis B treatment market will significantly increase over the next six years to reach $10.5bn in 2029, with analysts predicting a compound annual growth rate of 30%. According to the analysts, 71% of the sales in 2022 were attributed to Vemlidy and SciClone Pharmaceuticals’ Zadaxin, a synthetic polypeptide, indicating market dominance. GlobalData’s consensus forecasts predict that Vemlidy will generate $873m in sales in 2024. GlobalData is the parent company of Pharmaceutical Technology .

Pictured: Gilead's headquarters in Silicon Valley/iStock, Sundry Photography The FDA on Thursday expanded the label of Gilead Sciences’ antiviral drug Vemlidy (tenofovir alafenamide), opening up its use for the treatment of chronic hepatitis B virus infection in children aged six years and older. Its latest approval only covers pediatric patients with compensated liver disease and who weigh at least 25 kg. Vemlidy has previously been approved for chronic hepatitis B virus (HBV) in patients aged 12 years and older with compensated disease. It comes with a boxed warning for the severe acute exacerbation of hepatitis B after treatment. Frank Duff, senior vice president of virology at Gilead, in a statement called Vemlidy’s label expansion a “testament to the safety, tolerability and efficacy pro this therapy,” particularly in young children, who “require our best science and dedicated focus.” According to Gilead’s announcement, Vemlidy is a targeted prodrug of tenofovir that works by inhibiting the nucleoside analog reverse transcriptase enzyme, which RNA viruses use to convert their genetic material into DNA. Vemlidy was first approved in 2015 and has since become the recommended first-line treatment of chronic HBV in adult patients with compensated disease according to the American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines. Thursday’s label expansion was based on a 96-week Phase II trial, which compared Vemlidy with placebo in 18 patients and found that it could elicit “progressive increases in virological suppression,” according to Gilead. Vemlidy’s approval should help Gilead recover from its 4% revenue slip, as reported in its year-end 2023 financial report. The pharma suffered declining sales from its COVID-19 business, with its intravenous antiviral therapy Veklury (remdesivir) dropping 28% in the fourth quarter of last year. Gilead’s HIV franchise also took a 2% hit in the most recent quarter. Gilead’s potential recovery could be aided by a trio of deals that the pharma has struck in recent weeks. In February 2023, Gilead made a $4.3 billion investment in CymaBay Therapeutics and its lead asset seladelpar, which is being developed for primary biliary cholangitis. The companies announced the acquisition on the same day that seladelpar’s New Drug Application was accepted for FDA review, with a target action date of Aug. 14, 2024. Last month, Gilead also revealed that it secured up to $210 million in funding from life sciences investment company Abingworth to advance its antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) in non-small cell lung cancer. The pharma shortly after inked a $1.5 billion contract with Merus to discover trispecific T-cell engagers. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

The FDA expanded the label for Gilead’s hepatitis B drug Vemlidy on Thursday to patients as young as 6 years old. Vemlidy, or tenofovir alafenamide, is a once-daily treatment for chronic hepatitis B that pulled in $862 million in sales for Gilead in 2023, up from $842 million in 2022. The regulator originally approved the therapy in 2016 for adults with chronic hepatitis B infections and compensated liver disease. Then in 2022, the label was expanded to include patients who are at least 12 years old with the infection and compensated liver disease. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.