Sofosbuvir/velpatasvir submitted to US FDA for HCV genotype 1-6
Gilead press statement
On 28 October 2015, Gilead submitted a new drug application to the US FDA for a fixed dose combination of sofosbuvir/velpatasvir.
Sofosbuvir is a nucleotide analog polymerase inhibitor that was approved in the US in December 2013 and velpatasvir is an NS5A inhibitor previously developed as GS-5816.
The application is for treatment for HCV genotypes 1 to 6.
The European application is expected before the end of 2015.
Gilead press statement. Gilead submits new drug application to U.S. Food and Drug Administration for fixed-dose combination of sofosbuvir/velpatasvir for treatment of all six genotypes of hepatitis C. (28 October 2015).