Harvoni ledipasvir regulatory update

Health Canada approved Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic HCV genotype 1 infection in adults. FDA approved the product as Harvoni for the indication last month (see BioCentury, Oct. 13). In September, EMA's CHMP recommended approval of the product to treat chronic HCV infection (see BioCentury, Sept. 29). It is also under review in Australia and New Zealand. The drug is a fixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor. ...