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FDA Grants 'Priority Review' to Olysio & Sovaldi Hep C Combo
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iana5252:
The U.S. Food and Drug Administration (FDA) has granted priority review status to Medivir, in partnership with Janssen, for the supplemental New Drug Application (NDA) for Olysio (simeprevir) and Sovaldi (sofosbuvir) to treat genotype 1 of hepatitis C virus (HCV). On May 7, Medivir and Janssen filed the supplemental NDA for the 12-week, all-oral, interferon- and ribavirin-free regimen of the companies’ NS3/4A protease inhibitor Olysio and Gilead Sciences’ nucleotide analog polymerase inhibitor Sovaldi. The combination has already been widely prescribed off-label, but the FDA’s imprimatur would allow direct marketing of Olysio for this use.