Hepatitis C Combination Therapy Seeks Label Update

Janssen is asking the FDA to update the label of its once-daily hepatitis C virus (HCV) drug simeprevir (Olysio).

Olysio was originally approved in November 2014 for use with Gilead’s sofosbuvir (Solvadi) in adults with genotype 1 chronic HCV infection. The FDA approved this combination treatment regimen for 12 weeks in such patients without cirrhosis or 24 weeks in those with cirrhosis.

Now, Janssen has submitted a supplemental New Drug Application based on results from the phase 3 OPTIMIST-1 and OPTIMIST-2 trials.

OPTIMIST-1 showed sustained virologic response (SVR) in treatment-naive and treatment-experienced genotype 1 CHC patients without cirrhosis at 12 weeks after treatment (SVR12) with 12 and 8 weeks of Olysio and Solvadi treatment compared with a control group of patients previously treated with approved regimens containing a direct-acting antiviral, pegylated interferon, and ribavirin.

Similar results were seen in OPTIMIST-2, this time in treatment-naive and treatment-experienced genotype 1 CHC patients with cirrhosis.

“Olysio has contributed significantly to the care of people living with hepatitis C,” stated Richard Nettles, vice president of medical affairs at Janssen Therapeutics. “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.”