Janssen Submits Supplemental New Drug Application to U.S. FDA for All-Oral, Once-Daily OLYSIO® (Simeprevir) in Combination with Sofosbuvir

Filing Supported by Data from the Phase 3 OPTIMIST-1 and -2 Clinical Trials Evaluating OLYSIO® Combination Therapy in Hepatitis C Patients with and without Cirrhosis


TITUSVILLE, N.J., July 23, 2015 /PRNewswire/ -- Janssen Therapeutics, Division of Janssen Products, LP (Janssen), today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to update the label for once-daily, all-oral OLYSIO® (simeprevir). OLYSIO® is a hepatitis C virus (HCV) NS3/4A protease inhibitor, currently approved for use with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection as a 12-week treatment for patients without cirrhosis or a 24-week treatment regimen for patients with cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor marketed by Gilead Sciences, Inc.

OLYSIO® was approved in November 2014 in combination with sofosbuvir based on the Phase 2 COSMOS clinical trial. This sNDA is based on results from the Phase 3 OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naive and treatment-experienced genotype 1 CHC adult patients with cirrhosis.

"OLYSIO® has contributed significantly to the care of people living with hepatitis C. The availability of multiple treatment options is important to help offer an opportunity for cure, and we believe OLYSIO® will continue to play a meaningful role going forward," said Richard Nettles, M.D., vice president, Medical Affairs, Janssen Therapeutics. "We're pleased to submit the data from the Phase 3 OPTIMIST trials, which adds to the body of clinical information about this combination in patients with and without cirrhosis."

Results from the OPTIMIST trials were presented in April 2015 at The International Liver Congress™ 2015 of the European Association for the Study of the Liver (EASL) in Vienna.

About the OPTIMIST TrialsOPTIMIST-1 is a Phase 3, 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 eight weeks of treatment with SMV/SOF versus a historical control (patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon and ribavirin).
OPTIMIST-2 is a Phase 3, 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.
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