FDA OKs new formulation of Epclusa, expanding pediatric Indication

The US Food and Drug Administration has approved an expansion of the pediatric indication of Epclusa(sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as three years of age, regardless of HCV genotype or liver disease severity, says Gilead Sciences (Nasdaq: GILD).

The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200mg/velpatasvir 50mg and sofosbuvir 150mg/velpatasvir 37.5mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages three years and older is based on weight.

Treatment with Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). Sofosbuvir/velpatasvir is the only protease inhibitor-free, pangenotypic HCV regimen approved for patients as young as three years of age.