Gilead submits for approval of hepatitis C drug Sovaldi in Japan

27 June 2014

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.

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