
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