Gilead Submits NDA for Tablet Combination that Treats All Hep C Genotypes

November 4, 2015

Gilead has submitted an NDA for its single tablet combination of sofosbuvir and velpatasvir for the treatment of all six genotypes of hepatitis C.

Sofosbuvir was approved as the hep C treatment Sovaldi in December 2013, and velpatasvir is an investigational pan-genotypic NS5A inhibitor. The NDA is supported by four international Phase 3 trials that monitored 1,302 patients with all genotypes of infection and varying degrees of scarring from liver disease.

The tentatively named SOF/VEL combo product is the first fixed-dose combination of two pan-genotypic, direct-acting antivirals, says Norbert Bischofberger, Gilead’s chief scientific officer and executive vice president of R&D. The drug complements Gilead’s other HCV drugs, Sovaldi and Harvoni.

SOL/VEL already received breakthrough therapy designation from the FDA. Gilead says it plans to submit an application for regulatory approval in the EU by the end of the year.