Gilead Sciences, Inc. has announced the U.S. Food and Drug Administration’s (FDA) approval of the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets. This approval expands Vemlidy’s indication as a once-daily treatment for chronic hepatitis B virus (HBV) infection to include pediatric patients aged six years and older, weighing at least 25 kg, with compensated liver disease. Originally approved by the FDA in 2016 for adults with chronic HBV infection and compensated liver disease, Vemlidy’s efficacy and safety profile now extends to younger patients, offering a new treatment option for this demographic.
The drug is recommended as a preferred or first-line treatment for adults with chronic HBV infection by leading liver disease associations, reflecting its strong standing in the treatment landscape. The recent approval was supported by Week 96 data from a Phase 2 clinical trial involving pediatric patients, demonstrating progressive increases in virological suppression rates through Week 96 among both treatment-naïve and treatment-experienced children aged 6 to less than 12 years.
Dr. Frank Duff, Senior Vice President at Gilead Sciences, highlighted the significance of expanding Vemlidy’s indication for younger children, emphasizing the importance of providing effective and tolerable treatment options for this demographic. Gilead’s commitment to pediatric research through its Pediatric Center of Excellence, which coordinates clinical trials for treatments across various diseases, underscores the company’s dedication to addressing the unmet needs of pediatric patients.
However, Vemlidy comes with a boxed warning regarding post-treatment severe acute exacerbation of hepatitis B, advising close monitoring of hepatic function in patients discontinuing anti-hepatitis B therapy. This recent approval marks a meaningful advancement in the management of chronic HBV infection among pediatric patients, aligning with Gilead Sciences’ mission to deliver innovative therapies for diseases with high unmet medical needs.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
