Gilead submits for approval of hepatitis C drug Sovaldi in Japan

US biotech firm Gilead Sciences (Nasdaq: GILD) revealed this morning it has submitted a New Drug Application to Japan's Pharmaceutical and Medical Devices Agency (PMDA) for approval of its controversially high-priced sofosbuvir, a once-daily nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.

The data in the NDA support the use of sofosbuvir – trade name Sovaldi in the USA, Canada and Europe where it is already approved - with ribavirin (RBV) for 12 weeks in patients with genotype 2 HCV infection. If approved, sofosbuvir would form the basis of the first all-oral, interferon-free treatment regimen for genotype 2 patients in Japan.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20%-30% have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for certain patients.