Gilead submits NDA in Japan for sofosbuvir to treat patients with HCV

Gilead Sciences has submitted a new drug application to Japan’s Pharmaceutical and Medical Devices Agency to approve sofosbuvir to treat patients with chronic hepatitis C virus, according to a company press release.

Sofosbuvir (Sovaldi), a polymerase inhibitor, would be the first all-oral, interferon-free treatment regimen for genotype 2 hepatitis C virus (HCV)-infected patients in Japan if approved, the release said.

“There is an urgent need in Japan for new HCV treatment options that are more effective, well tolerated and simpler for patients,” Norbert Bischofberger, PhD, Gilead’s chief scientific officer and executive vice president of research and development, said in the release. “Based on phase 3 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. We look forward to working with the PMDA as the agency reviews our application.”

According to the release, Japan has one of the highest rates of liver cancer due to HCV and 20% to 30% of the 1 million people infected with HCV have the genotype 2 strain. The only approved treatments for HCV in Japan are 24 to 48 weeks of pegylated interferon injections.

Gilead is currently conducting a second phase 3 trial that includes therapy with 400 mg sofosbuvir in combination with 400 mg ledipasvir, with or without ribavirin, to treat genotype 1 HCV patients. Gilead expects to file for approval in Japan for this genotype 1 therapy later this year, the release said.

Sofosbuvir already has been approved in the US, Canada and the European Union.