Janssen submits sNDA to US FDA for once-daily Olysio in combo with sofosbuvir

Janssen Therapeutics, Division of Janssen Products, LP (Janssen), has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir), 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-naïve and treatment-experienced genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for treatment-naïve 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.