Gilead Sciences has submitted a new drug application to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of its sofosbuvir for treatment of chronic hepatitis C virus (HCV) infection.
The data in the new drug application supports the use of sofosbuvir, a once-daily nucleotide analog polymerase inhibitor, with ribavirin for 12 weeks in patients with genotype 2 HCV infection.
Gilead Sciences’ new drug application is supported by positive outcome from a Japanese Phase III clinical study (Study GS-US-334-0118) among 153 treatment-naive and treatment-experienced genotype 2 patients.
The company’s application is also supported by sustained virologic response 12 weeks after completing therapy (SVR12) results from four international Phase III studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.
A second Japanese Phase III clinical trial (Study GS-US-337-0113) has also been conducted by the company. The Phase III study is evaluating a once-daily fixed-dose combination of sofosbuvir 400mg and the NS5A inhibitor ledipasvir 90mg, with and without ribavirin, for treatment of genotype 1 HCV infected patients.
Gilead Sciences reported SVR12 results from the study that took place this month. The company plans to file for approval of the ledipasvir/sofosbuvir combination in Japan in the second half this year.
Gilead Sciences chief scientific officer and research and development executive vice-president Norbert Bischofberger said: "Based on Phase III studies, we believe that sofosbuvir has the potential to provide high cure rates among genotype 2 patients in just 12 weeks of interferon-free therapy.
According to Gilead Sciences, sofosbuvir represents its first drug application in Japan. The company claims that if approved, sofosbuvir would be the first all-oral treatment regimen for patients in Japan with genotype 2 HCV.
Sofosbuvir is an investigational product in Japan and its safety and efficacy has not yet been established.
Image: Illustration of heppatitis virus. Photo: courtesy of freedigitalphotos.net.