Olysio sNDA Submitted for Labeling Update
Janssen Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.
The sNDA is based on results from two Phase 3 trials. OPTIMIST-1 is a randomized, open-label trial to investigate the efficacy and safety of the all-oral regimen of simeprevir and sofosbuvir (SMV/SOF) among treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis. The primary study endpoint is sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and 8 weeks of treatment with SMV/SOF versus a historical control. About 97% of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87% among the historical control.
OPTIMIST-2 is an open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis. The primary endpoint is SVR12 with SMV/SOF versus a historical control. Twelve weeks of treatment with SMV/SOF resulted in SVR12 rates of 84% (n=86/103), which was superior to the SVR12 rate of 70% in the historical control.
Olysio (simeprevir) is an NS3/4A protease inhibitor. Sofosbuvir (Gilead) is a nucleotide analog NS5B polymerase inhibitor.
For more information call (800) 526-7736 or visit JanssenTherapeutics.com.