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).

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