US FDA approval for Gilead's hepatitis C drug Sovaldi

US antiviral biotech specialist Gilead Sciences (Nasdaq: GILD) says that the Food and Drug Administration has approved its Sovaldi (sofosbuvir), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection; the agency last month cleared Johnson & Johnson’s Olysio (simeprevir) for marketing (The Pharma Letter November 25). The product also gained a favorable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) last month in a compassionate-use program (TPL November 25).

Sovaldi is projected to be Gilead’s biggest product, generating $1.9 billion in revenue next year, and $6.6 billion in 2016, according to the average of eight analysts’ estimates compiled by Bloomberg.