Gilead's HCV Drug Epclusa Gets FDA Nod for Expanded Age Group

Gilead Sciences, Inc. GILD announced that the FDA has approved the supplemental new drug application (sNDA) to update its hepatitis C infection (HCV) drug, Epclusa’s label. The sNDA sought approval of Epclusa for the treatment of chronic HCV in pediatric patients aged six years and above or weighing at least 17 kg, regardless of HCV genotype or liver disease severity.

Notably, Epclusa was approved in 2016 by the FDA and European Medicines Agency (EMA) for treating adult patients with chronic HCV infection. The drug is currently under review in Europe for use in pediatric patients aged six to less than 18 years.

Per the company, Epclusa is the first pan-genotypic, protease inhibitor-free regimen to be approved in the United States for adults and children to address the given indication. The recommended dosage of Epclusa is based on weight and liver function in children aged six years and above.

The approval was based on data from the open-label phase II Study 1143 study. The safety profile of Epclusa in the pediatric patient population was generally consistent with what was observed in adults.

However, the product label for Epclusa comes with a boxed warning in the United States.

Shares of Gilead have rallied 21% in the past year against the industry’s decline of 17.7%.

We remind investors that Gilead’s HCV franchise has witnessed a significant slowdown across key markets, including the United States and Europe. Nevertheless, Gilead remains a dominant player in the HIV market.

Meanwhile, Gilead has been in the spotlight recently as its experimental candidate remdesivir showed promise in treating patients with COVID-19. Last month, Gilead initiated two phase III studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19. These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers, primarily across the Asian countries.

We note that efforts to develop a vaccine for combating the deadly novel coronavirus accelerated in the last couple of weeks.  Earlier in the week, Moderna, Inc., MRNA dosed the first participant in the phase I study of mRNA vaccine (mRNA-1273) against SARS-CoV-2. Quite a few others like Novavax, Inc. NVAX and Inovio Pharmaceuticals, Inc. INO are also developing vaccines to treat the disease.

Zacks Rank

Gilead currently carries a Zacks Rank #4 (Sell).

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