Gilead Wins EU Approval for High-priced Hep C Drug

Nov. 18, 2014

Gilead Sciences has been granted marketing authorization by the European Commission for its next-generation hepatitis C drug, opening the door for the drug to be sold in 28 countries.

The drug, Harvoni, is the first once-daily tablet targeting chronic hepatitis C. It was approved last month by the U.S. FDA and priced at a staggering $95,000. European pricing has yet to be determined and must be negotiated with individual countries.

Harvoni combines the drug ledipasvir with Sovaldi, Gilead's first-generation hepatitis C drug, which was approved in the U.S. in December 2013 and in Europe in January 2014.

Read the Gilead press release