Harvoni ledipasvir regulatory update

EMA's CHMP recommended approval of the MAA for Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic HCV infection. The product was evaluated under EMA's accelerated assessment mechanism. Harvoni is a fixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor.

Sovaldi plus ledipasvir is under Priority Review in the U.S. to treat chronic HCV genotype 1 infection, with an Oct. 10 PDUFA date. The combination has breakthrough therapy designation in the U.S. By year end, Gilead plans to submit a regulatory application in Japan for the combination. ...