FDA nod for new therapy for pediatric patients with any strain of hepatitis C

The US Food and Drug Administration yesterday approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children aged six years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis.

The FDA granted Priority Review of Epclusa to Gilead Sciences (Nasdaq: GILD), whose shares gained 4.23% to $81.90 in after-hours trading following the news. The company’s application for such indications in Europe is under European Medicines Agency review. Epclusa generated sales of almost $2 billion in 2019.

“While the treatment of HCV has been transformed in recent years, physicians caring for some children have still needed to take several factors into consideration, including genotype and liver disease severity, when selecting the appropriate treatment plan,” said Dr Kathleen Schwarz, Professor of Pediatrics, Johns Hopkins University School of Medicine, adding: “The expanded approval of Epclusa can help eligible children living with HCV combat this life-threatening and debilitating disease.”