Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24 September 2014

US biotech major Gilead Sciences (Nasdaq: GILD) has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400mg for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults.

The data submitted in the NDA, which include a Japanese Phase III study showing 100% SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naive and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin (RBV).

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