www.fdanews.com/articles/174829-fda-awards-priority-review-to-gilead-for-hep-c-combo-drug
![GILEAD.gif](https://www.fdanews.com/ext/resources/test/Drug-Images/GILEAD.gif?t=1580164042&width=430)
FDA Awards Priority Review to Gilead for Hep C Combo Drug
January 11, 2016
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.