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

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).

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 in Japan chronically infected with HCV, 70%-80% are infected with the genotype 1 strain of the virus.