Biotech Values

[DewDiligence]

GILD submits NDA for 12-week regimen of Sovaldi/Velpatasvir* for all HCV genotypes:

http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=2103809

Gilead Sciences, Inc…today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) [Sovaldi] and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

The NDA is supported by clinical studies exploring the use of 12 weeks of SOF/VEL for patients with genotype 1-6 HCV infection, including patients with compensated cirrhosis and 12 weeks of SOF/VEL with ribavirin for patients with decompensated cirrhosis.

Although GILD is nominally seeking SOV/VEL approval for all genotypes, Harvoni will remain GILD’s preferred treatment for GT1 patients, especially those who qualify for an 8-week duration.

Thus, the commercial impetus for SOF/VEL is twofold: i) having a better treatment option than Sovaldi + ribavirin for non-GT1 patients—particularly GT3 (where Sovaldi + ribavirin requires 24 weeks); and ii) having a pan-genotypic option for use in situations (i.e. locations) where genotyping is not practical due to the cost or unavailability of the genotyping test.

*f/k/a GS-5816.