Harvoni ledipasvir regulatory update

FDA approved once-daily Harvoni ledipasvir/sofosbuvir from Gilead to treat chronic HCV genotype 1 infection. The product is the first oral combination therapy for the indication that does not require interferon or ribavirin. Harvoni is a fixed-dose combination of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, and ledipasvir, an HCV NS5A protein inhibitor. FDA said Harvoni is the third drug approved by the agency in the past year for HCV infection and the seventh new drug approved with breakthrough therapy designation. The drug is entitled to 5-year exclusivity as a new chemical entity (NCE).

Treatment-naive patients without cirrhosis who have baseline HCV viral load <6 million IU/mL can be considered for an 8-week course of Harvoni, 4 weeks shorter than previously available therapy. Gilead said a 12-week course of Harvoni will cost $94,500, which is similar to Sovaldi plus interferon and ribavirin, and an 8-week course will cost $63,000. EMA's CHMP recommended approval of an MAA for Harvoni last month (see BioCentury, Sept. 29). ...