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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.