Hep C Discussion Forum

It was less than six months ago that OLYSIO (simeprevir) in combination with pegylated interferon and ribavirin, commonly referred to as triple therapy was first approved by the U.S. Food and Drug Administration (FDA) to treat genotype 1 chronic hepatitis C in adults with compensated liver disease. Now, Janssen has submitted a Supplemental New Drug Application (sNDA) to the FDA that could expand the way physicians treat patients with chronic hepatitis C using OLYSIO.

The sNDA filed by Janssen R&D seeks approval to use OLYSIO in combination with the nucleotide inhibitor sofosbuvir developed by Gilead Sciences, Inc. for the treatment of genotype 1 chronic hepatitis C (HCV) in adult treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis. If approved, it would offer patients with chronic hepatitis C a once-daily all-oral treatment combination of OLYSIO and sofosbuvir.

To date, the launch of OLYSIO in the U.S. has been one of the most successful in Janssens history, which has been possible due to the efforts of a wide ranging team representing various R&D, commercial and support functions. The end result is that OLYSIO has impacted many people living with chronic hepatitis C. This sNDA submission looks to build on that foundation towards making even more of a difference for patients.