Medivir AB announced that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir), in combination with sofosbuvir, for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C. The sNDA was filed in May by Medivir’s strategic partner Janssen Research & Development LLC.The regulatory submission for Olysio and sofosbuvir is supported by data from the Phase 2 COSMOS study which included treatment-naïve patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores).
“The Priority Review designation by the FDA shows the high priority and great importance of making interferon-free treatment regiments available to the many difficult to cure hepatitis C patients groups,” said Charlotte Edenius, EVP Development, Medivir.
Date: July 15, 2014
Source: Medivir
