With a unanimous recommendation from a U.S. Food and Drug Administration panel, Gilead’s investigational nucleotide analogue sofosbuvir is now weeks from a likely FDA approval for the treatment of hepatitis C virus (HCV), Reuters reports. Voting 15 to 0, the FDA’s Antiviral Drugs Advisory Committee agreed that research supports the approval of the once-a-day drug to treat genotypes 2 and 3 of hep C when given in combination with ribavirin.
The decision immediately followed the panel’s recommendation of Janssen’s investigational protease inhibitor simeprevir, a drug that should receive a final decision from the FDA in late November. The target date for sofosbuvir’s approval is December 8.
The panel made its decision based on data from four Phase III studies: NEUTRINO, FISSION, POSITRON and FUSION. In these studies, a 12 to 16 week sofosbuvir-based regimen proved equivalent or superior to the current available therapies when considering the rate of those who achieved a sustained virologic response (SVR, considered a cure). The FDA also took into account a Phase III study called VALENCE in which participants with genotype 3 of the virus received sofosbuvir and ribavirin for 24 weeks.
To read more about the hep C drug pipeline, click here.
To read the Reuters story, click here.
To read a Gilead release, click here.
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