FDA approves Gilead's Harvoni, the first combo pill for hepatitis C

As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’ (Nasdaq: GILLD) Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni is the first, all oral combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection, the FDA noted.

Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved Gilead HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. Sovaldi generated sales of about $5.8 billion in the first half of 2014, making it one of the most profitable drug launches of all time.