FDA Awards Priority Review to Gilead for Hep C Combo Drug

The FDA has granted priority review for Gilead Sciences’ once-daily, single-tablet combination of Sovaldi and NS5A inhibitor velpatasvir for hepatitis C.

Previously classified as a breakthrough therapy, the drugmaker’s case for the NDA stems from four international Phase 3 trials that tested more than 1,000 patients in all six HCV genotypes. Results from those trials showed sustained viral response in 98 percent of patients.

The FDA has set a PDUFA decision date of June 28. Gilead’s combination drug also is being evaluated in Europe.