Priority Review at FDA for combination Sovaldi (sofosbuvir)+ GS 5816 (velpatasvir) to treat genotype 1-6 hepatitis C- Gilead Sciences
The FDA has granted priority review to a New Drug Application (NDA) from Gilead Sciences, for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi in December 2013, and velpatasvir (VEL)(GS 5816), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
Gilead filed the NDA for SOF/VEL on October 28, 2015, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.