Gilead's HCV Drug Epclusa Gets FDA Nod For Expanded Age Group
Zacks Investment Research | Mar 20, 2020 12:01AM ET
Gilead Sciences, Inc. (NASDAQ: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 Zacks Investment Research
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