The FDA has given priority review status to a new drug application for Gilead Sciences' sofosbuvir and velpatasvir as a treatment for chronic genotype 1-6 hepatitis C virus infection.
The FDA has given priority review status to a new drug application (NDA) for Gilead Sciences’ sofosbuvir (Solvadi) and velpatasvir as a treatment for chronic genotype 1-6 hepatitis C virus infection.
Gilead filed the NDA in October 2015, and the FDA planned a target action date for the combination by June 28, 2016.
The combination of the nucleotide analog polymerase inhibitor and the investigational pan-genotypic NS5A inhibitor was supported by 4 phase 3 trials in its NDA.
The NDA also included data about use of the treatment for 12 weeks among patients with all genotypes of hepatitis C, including those with compensated cirrhosis.
Sovaldi, originally approved in December 2013, is designed for the treatment of hepatitis C genotypes 1, 2, 3, and 4 infections.
“As the first fixed-dose combination of 2 pan-genotypic, direct-acting antivirals, SOF/VEL [sofosbuvir/velpatasvir] represents an important step forward in the treatment of patients with hepatitis C,” said Norbert Bischofberger, executive vice president of research and development and chief scientific officer at Gilead, in a press release.