EC Approves Gilead’s Hepatitis C Drug Harvoni
The European Commission approved Gilead’s hepatitis C drug Harvoni, a decision that comes on the heels of approvals in the U.S., Canada and New Zealand.
Approval was based on data from three phase III studies that found Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) showed cure rates of up to 99 percent. The product is the first once-daily, single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infections in adults, Gilead said.
The drug is indicated for an eight-, 12- or 24-week course, depending on prior treatment history, genotype, and cirrhosis status. “Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades,” said Graham Foster, professor of hepatology at Queen Mary University of London.
The approval follows a positive recommendation by the European Medicines Agency in September. Harvoni won approval by the FDA and Health Canada last month, and in New Zealand earlier this month. The average price for Harvoni varies from $63,000 for eight weeks of treatment to $94,500 for 12 weeks. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.