Epclusa FDA approval : Gilead Sciences has secured an expanded approval for Epclusa (sofosbuvir 400mg/velpatasvir 100mg; sofosbuvir 200mg/velpatasvir 50 mg) from the US Food and Drug Administration (FDA), which covers treatment of chronic hepatitis C infection (HCV) in children.

The approval is for the drug to be used for the treatment of children aged six years and older or weighing at least 37 pounds (17 kilograms), and having any of the six hepatitis C genotypes or strains and irrespective of their liver disease severity.

Epclusa is now the first pan-genotypic, protease inhibitor-free regimen to be approved in the US for both adults and children.

The Gilead Sciences drug in combination with ribavirin already has approval for the treatment of pediatric patients with severe cirrhosis, aged six years and older or weighing at least 37 pounds. As a monotherapy, Epclusa was previously approved by the FDA for the treatment of hepatitis C in adults.

Commenting on the latest Epclusa FDA approval, Debra Birnkrant – director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said: “This approval will provide additional treatment options for children and adolescents with HCV.

“This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”

The latest FDA approval of Epclusa has been driven by the findings of a phase 2, open-label clinical trial (Study 1143) that featured 175 children who were treated with the drug for 12 weeks.

In children, aged between 12 and 18 years, treatment with Epclusa resulted in a cure rate of 93%. On the other hand, in children, aged between six and 12 years, the cure rate was 93% for those with genotype 1 HCV infection, 91% in those with genotype 3 HCV infection, and 100% in those with genotype 2 and genotype 4 HCV infection.

The safety profile of Epclusa in children, aged six years and older was generally on par with that seen in clinical trials in adults.

Merdad Parsey – Chief Medical Officer at Gilead Sciences, commenting on the latest Epclusa FDA approval, said: “Gilead’s continued commitment to HCV elimination includes bringing our medicines to the most difficult-to-cure populations and today’s decision by the FDA represents an important step toward that goal.

“With consistently high cure rates in clinical trials and in the real world, Epclusa has the potential to help many of the children living with HCV in the United States.”

  Debra Birnkrant, Epclusa, FDA, Gilead Sciences, hepatitis C, Merdad Parsey, US Food and Drug Administration