FDA Grants Medivir's OLYSIO Priority Review

Tue, 07/15/2014 - 11:15am

Medivir AB announced that the 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 II 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“, says Charlotte Edenius, EVP Development, Medivir.


Share this Story

You may login with either your assigned username or your e-mail address.
The password field is case sensitive.