FDA OKs New Hepatitis C Combo Drug from Gilead

The US Food and Drug Administration (FDA) has approved Gilead Sciences’ Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg), an all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. 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).

The FDA granted Epclusa priority review and breakthrough therapy designation, which is given to investigational medicines that may offer major advances in treatment over existing options.

HCV treatments are an important part of Gilead’s product portfolio. Sovaldi (sofosbuvir) posted 2015 sales of $5.3 billion, and Harvoni (ledipasvir and sofosbuvir) posted 2015 sales of $13.9 billion.

Source: Gilead Sciences

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