Medivir AB reported that Janssen Pharmaceutical R&D Ireland (Janssen) has been informed by the Japanese Ministry of Health, Labor and Welfare (MHLW) that simeprevir has been approved for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection.
“The approval in Japan is a very important step in providing patients with new treatment options. It is the first approval based on the series of global filings that our partner initiated during 2013. Japan is commercially a very exciting market with a huge unmet medical need among hepatitis C patients,” said Maris Hartmanis, CEO of Medivir.
The approval in Japan triggers a milestone payment of €5m to Medivir.
Simeprevir, a new direct-acting antiviral agent (DAA), is a protease inhibitor for the treatment of genotype 1 chronic HCV infection. Simeprevir is administered once-daily for 12 weeks as part of a “triple combination” with pegylated interferon and ribavirin followed by an additional 12 or 36 weeks of pegylated interferon and ribavirin alone.
In the CONCERTO clinical trials, simeprevir, as part of a regimen with pegylated interferon and ribavirin, demonstrated strong efficacy, with 89 percent of patients with previously untreated genotype 1 HCV infection achieving a sustained virological response (SVR). The primary endpoint in all clinical studies for simeprevir was a SVR 12 weeks after the last dose of treatment. In studies that included patients who had relapsed after stopping previous HCV treatment, results showed an SVR rate of 96 percent. These results were presented in June at The Japan Society of Hepatology.
Date: September 27, 2013