Olysio + Sofosbuvir sNDA Designated Priority Review
Medivir AB and Janssen R&D announced that the FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.
The sNDA submission was based on data from the Phase 2 COSMOS study which included treatment-naïve patients with advanced fibrosis (METAVIR F3–F4 scores) and prior unll-responders with all stages of liver fibrosis (METAVIR F0–F4 scores).
Olysio is a NS3/4A protease inhibitor already approved for the treatment of chronic hepatitis C infection, in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.
For more information call (800) 457-6399 or visit JanssenRnD.com.