Label update submitted to FDA for simeprevir and sofosbuvir in Hepatitis C- Janssen

Janssen has submitted a supplemental New Drug Application to the FDA to update the label for once-daily, all-oral Olysio (simeprevir), currently approved in the U.S. 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. Olysio was approved in November 2014 in combination with sofosbuvir based on the phase II COSMOS clinical trial.

This sNDA is based on results from the phase III OPTIMIST-1 and OPTIMIST-2 trials, which evaluated 12 and eight weeks of therapy for genotype 1 CHC adult patients without cirrhosis, and 12 weeks of therapy for genotype 1 CHC adult patients with cirrhosis. Results from the OPTIMIST trials were presented in April 2015 at The International Liver Congress 2015.