- Gilead on Monday announced its experimental pan-genotypic Hep C combo treatment had been granted priority review by the FDA. Its fixed-dose combination of Sovaldi and velpatasvir is designed to treat genotypes 1 through 6 of the hepatitis C virus. Sovaldi is currently approved for genotypes 1-4.
- The California-based biotech got further good news on Wednesday, saying two Phase 3 clinicial trials showed its Hep B drug was as effective, but safer, as already approved Viread.
- The PDUFDA date for the Solvaldi/velpatasvir combo treatment is set for June 28, 2016.
Gilead has performed well on the back of its Hepatitis C blockbuster drugs Sovaldi and Harvoni. Together the two drugs pulled in $14.2 billion in sales worldwide in the first nine months of 2015. However, sales of Sovaldi have declined this year.
The combination treatment of Sovaldi and velpatasvir would expand the number of treatable genotypes. It is also under review in the European Union.
Gilead also hopes its new experimental Hep B drug (tenofovir alafenamide or TAF) will prove a worthy successor to its approved med Viread. The two Phase 3 trials demonstrated TAF was "non-inferior" to Viread, along with improved renal and bone laboratory safety parameters.
Based on the two studies, Gilead plans to submit TAF for regulatory approval in the US and the EU in the first quarter of 2016.