FOSTER CITY, Calif. – Gilead Sciences Inc . (NASDAQ: NASDAQ:) announced that 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. aged six years or older and weighing at least 25 kg with compensated liver disease.
This approval follows the FDA’s initial greenlight of the drug in 2016 for use in adults and its subsequent extension in 2022 to pediatric patients ages 12 and older. Vemlidy is recognized by leading health authorities as the preferred or first-line treatment for adults with chronic HBV with compensated liver disease.
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 study 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, emphasized the importance of early treatment of hepatitis B in children to prevent serious complications such as cirrhosis and liver cancer.
Gilead Senior Vice President Frank Duff highlighted the commitment to pediatric research, citing the work of Gilead’s Pediatric Center of Excellence in coordinating clinical trials for various diseases, including hepatitis B.
Despite the optimism surrounding the approval of Vemlidy, the drug’s label contains a warning about the risk of severe acute exacerbation of hepatitis B if treatment is stopped. The label also includes precautions regarding the development of HIV-1 resistance in patients coinfected with HBV/HIV-1, the risk of new onset or worsening renal failure and lactic acidosis, and severe hepatomegaly with steatosis.
The most common adverse events reported in the pediatric population at Week 96 included nasopharyngitis, headache, and upper respiratory tract infections, while upper abdominal pain and metabolic nephropathy were the only study drug-related adverse events reported in more than one participant.
Gilead Sciences has been a key player in the treatment of liver disease for more than two decades, and this latest FDA approval represents another step forward in its mission to address the unmet treatment needs of children.
This announcement is based on a press release from Gilead Sciences.
Insights on InvestingPro
As Gilead Sciences (NASDAQ: GILD) celebrates the FDA’s approval of Vemlidy for pediatric use, investors are keeping a close eye on the company’s financial health and market position. According to data from InvestingPro, Gilead boasts a solid market capitalization of $90.95 billion, underscoring its significant presence in the biopharmaceutical sector. The company’s P/E ratio stands at a competitive 16.01, with its adjusted P/E for the trailing 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 near-term earnings growth, a positive sign for value investors.
InvestingPro tips highlight that Gilead has not only increased its dividend for 9 consecutive years, but also operates at a strong free cash flow yield, which could be attractive to income-focused investors. Furthermore, with a dividend yield of 4.22% according to the most recent data, Gilead demonstrates its commitment to returning value to shareholders.
For those considering Gilead an investment opportunity, it’s worth noting that analysts expect the company to remain profitable this year. With a solid track record of profitability over the past twelve months, Gilead stands out as a leading player in the biotechnology sector.
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