FDA approves Sovaldi HCV combo
FDA announced Friday it has approved Gilead's HCV combination treatment, Harvoni, a mixture of Sovaldi (sofosbuvir) and ledipasvir.
Harvoni marks the agency's third approved drug for chronic HCV in the past 12 months, after Gilead's Sovaldi and Janssen's Olysio (simeprevir)—which were approved in November 2013 and December 2013 respectively. Harvoni is the seventh drug to be approved through FDA's Breakthrough Therapy designation pathway.
In trials, the sofosbuvi-ledipasvir combo demonstrated cure rates of up to 99% in patients with and without cirrhosis, after 1 2 weeks. In patients who had already tried other HCV medicines (i.e. treatment-experienced) Harvoni cured 94% of patients in 12 weeks, and 99% of patients in 24 weeks. In all trials supporting the drug's submission, the addition of ribavirin did not increase response rates.
ISI analyst Mark Schoenebaum wrote in an investor note Friday afternoon that the drug is predicted to cost $95,000 for a 12 week regimen. The average price for genotype 1 patients is expected to be $80,000, according to ISI's estimates.
Schoenebaum also noted—based on Gilead's prior commentary—that the drugmaker expects 45% of genotype 1 patients to receive 8 weeks of therapy. The remaining 55% are expected to receive 12 weeks of therapy.
This HCV combo received a positive opinion from the EU's Committee for Medicinal Products for Human Use on Friday, September 26.