FDA approves Olysio for Hepatitis C-Janssen R&D

The FDA has approved Olysio (simeprevir), from Janssen R&D, for the treatment of chronic Hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. Olysio may benefit patients with chronic Hepatitis C, including those who are treatment naive or who have failed prior interferon-based therapy.

Approval was based on efficacy and safety results from three pivotal Phase III studies � QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients who have relapsed after prior interferon-based treatment � as well as data from the Phase IIb ASPIRE study in prior non-responder patients. Each evaluated Olysio dosed once daily in combination with pegylated interferon and ribavirin versus treatment with placebo plus pegylated interferon and ribavirin. Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80% of patients in the group receiving Olysio achieved SVR12 compared with 50% of patients in the placebo groups. In PROMISE, 79% of prior-relapser patients in the simeprevir group of the study achieved SVR12 compared with 37 percent of patients on placebo.

The treatment was approved in September 2013 in Japan under the trade name Sovriad and in November 2013 in Canada under the trade name Galexos for the treatment of genotype 1 Hepatitis C. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April 2013.