NDA for Olysio and sofosbuvir submitted to FDA for HCV-Janssen
Janssen Research & Development has submitted a Supplemental New Drug Application to the FDA for Olysio (simeprevir) in combination with sofosbuvir, developed by Gilead Sciences. This regulatory submission is for the treatment of genotype 1 chronic Hepatitis C (HCV) in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis. Olysio is currently approved for the treatment of chronic Hepatitis C infection as a component of a combination antiviral treatment regimen.
The regulatory submission for Olysio and sofosbuvir is supported by data from the Phase II COSMOS study which included treatment-naive patients with advanced fibrosis (METAVIR F3 to F4 scores) and null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores). In April 2014, Janssen announced initiation of the Phase III OPTIMIST trials examining the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of chronic genotype 1 HCV infection.
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