A Food and Drug Administration (FDA) panel voted 15-0 to approve an experimental hepatitis C drug.
The drug, called sofosbuvir, is made by Gilead Sciences (GILD) and has been approved to treat genotype 2 and genotype 3 of hepatitis C when combined with existing treatments. The FDA doesn’t have to follow the advice of its panels, but it often does. If approved, sofosbuvir will become the first all-oral treatment of genotype 2 and genotype 3. The vote to approve the drug has been called “historic” and a “game-changer.” The panel also approved using the drug along with ribavirin and interferon to treat genotype 1 and genotype 4 patients that have yet to undergo therapy. Panelist also advised Gilead to allow other companies to use the drug for studies of other oral medicines that are waiting to be used, reports Reuters.
Gilead currently has two studies running an all-oral regimen for genotype 1 that is expected to produce results sometime next year.