Janssen has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for approval of a combination of the company’s Olysio (simeprevir) and Gilead Sciences’ Sovaldi (sofosbuvir) to treat genotype 1 of hepatitis C virus (HCV).
The American Association for the Study of Liver Diseases currently recommends 12 weeks of the NS3/4A protease inhibitor Olysio and the NS5B polymerase inhibitor Sovaldi plus ribavirin for the treatment of those people with genotype 1 of hep C who are ineligible to receive interferon. However, the combination is not currently approved by the FDA, so physicians must prescribe it off label. Gaining FDA approval would not only grant Janssen the permission to market Olysio as a part of this combination therapy, but would also allow ribavirin to be taken out of the mix.
“Hepatitis C places a significant burden on the lives of those infected and if left untreated may cause significant damage to the liver, including cirrhosis and complications such as liver failure,” said Gaston Picchio, hepatitis disease area leader at Janssen. “This filing brings us closer to potentially offering these patients a once-daily all-oral treatment combination that includes the direct-acting antiviral agents simeprevir and sofosbuvir.”
Janssen provided evidence to the FDA of the combination therapy’s efficacy—in the mid-90 percent rage—in the first two cohorts of the COSMOS trial, which included treatment-naive people with advanced fibrosis and null responders with all levels of fibrosis. Results from COSMOS were presented at medical meetings in the spring and in the fall of 2013.
To read the press release, click here.