FOSTER CITY, Calif. - Gilead Sciences Inc . (NASDAQ: NASDAQ:GILD) announced the U.S. Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide) 25 mg tablets for the treatment of chronic hepatitis B virus (HBV) infection in pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease.
This approval follows the medication's initial green light by the FDA in 2016 for adult use and its subsequent extension in 2022 to pediatric patients aged 12 and above. Vemlidy is recognized as a preferred or first-line treatment for adults with chronic HBV with compensated liver disease by leading health authorities.
The recent expansion to younger children is based on Week 96 data from a Phase 2 clinical trial, which demonstrated efficacy and safety in patients aged 6 to less than 12 years. The trial compared Vemlidy to placebo, with participants showing progressive increases in virological suppression, a key measure of the treatment's success in managing the virus.
Dr. Chaun-Hao Lin, Associate Professor of Clinical Pediatrics at the Krek School of Medicine of USC, highlighted the importance of early treatment for hepatitis B in children to prevent serious complications such as cirrhosis and liver cancer.
Gilead's Senior Vice President, Frank Duff, underscored the commitment to pediatric research, citing the work of the Gilead Pediatric Center of Excellence in coordinating clinical trials for various diseases, including hepatitis B.
Despite the optimism surrounding Vemlidy's approval, the drug's label contains a boxed warning about the risk of severe acute exacerbation of hepatitis B upon discontinuation of treatment. The label also includes precautions regarding the development of HIV-1 resistance in HBV/HIV-1 coinfected patients, the risk of new onset or worsening renal impairment, and lactic acidosis and severe hepatomegaly with steatosis.
The most common adverse events reported in the Week 96 pediatric population included nasopharyngitis, headache, and upper respiratory infections, with abdominal pain upper and metabolic nephropathy being the only study drug-related adverse events reported in more than one participant.
Gilead Sciences has been a key player in liver disease treatment for over two decades, and this latest FDA approval represents another step in its mission to address unmet treatment needs for children.
This announcement is based on a press release statement from Gilead Sciences.
InvestingPro Insights
As Gilead Sciences (NASDAQ: GILD) celebrates the FDA's approval of Vemlidy for pediatric use, investors are eyeing the company's financial health and market position. According to InvestingPro data, Gilead boasts a robust market capitalization of $90.95 billion, underlining its significant presence in the biopharmaceutical industry. The company's P/E ratio stands at a competitive 16.01, with an adjusted P/E for the last twelve months of Q4 2023 at an even more attractive 12.09. This indicates that the company is trading at a low price relative to its near-term earnings growth, a positive sign for value investors.
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