Gilead's latest hep C drug Epclusa OKed by FDA

There was good news today for US biotech giant Gilead Sciences (Nasdaq: GILD), when the US Food and Drug Administration gave its approval for the company’s Epclusa (sofosbuvir/velpatasvir), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Following the announcement, Gilead’s shares rose more than 4% to $81.42 by mid-morning trading. Gilead already has two of the best selling HCV drugs, Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir), which generated combined sales of $4.29 billion in first-quarter 2016. However, one of the biggest problems with Harvoni and Sovaldi is that the drugs are indicated for only certain genotypes of Hepatitis C.

Epclusa is also the first single tablet regimen 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). Just last month, the European Medicines Agency recommended approval of Epclusa, with a final decision probably expected in August.