Janssen's Olysio, Sofosbuvir Combo For HCV Earns FDA Nod Of Approval

Janssen Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted approval for Olysio (simeprevir) in combination with sofosbuvir as a once-daily, all-oral, interferon- and ribavirin-free treatment option for patients with genotype 1 chronic hepatitis C (CHC) infection.

Olysio is a hepatitis C virus (HCV) NS3/4A protease inhibitor co-developed by Janssen R&D Ireland and Medivir AB as treatment of CHC infection. Olysio is designed to be part of a combination antiviral treatment regimen. The FDA approved Olysio last year in combination with pegylated interferon and ribavirin in genotype 1 infected patients with liver disease, including cirrhosis.

Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences. Last month the FDA approved sofosbuvir in combination with ledispavir (brand name Harvoni) for HCV genotype 1 infection.

The approval for the Olysio and sofosbuvir combination was supported by positive data from the Phase 2 COSMOS study wherein 95 percent of patients treated with the 12-week combo therapy regimen achieved sustained virologic response (SVR12) or cure. Data from the study was published in the July edition of the journal The Lancet.

“It's a very encouraging time for patients with chronic hepatitis as the advent of new direct-acting treatment combinations, like Olysio plus sofosbuvir, offer all-oral, interferon- and ribavirin-free treatment options. The availability of multiple treatment options is important to physicians and patients so optimal treatment decisions can be made, given the complexity of the disease and diversity of patient population,” said Eric Lawitz, lead investigator for the COSMOS clinical study and professor of medicine at the University of Texas Health Science Center.

Dr. Gaston Picchio, Hepatitis disease area leader at Janssen Research & Development, said, “We’re pleased that an interferon-free, ribavirin-free OLYSIO-based combination is now approved in the United States for patients with genotype 1 chronic hepatitis C infection. The availability of multiple treatment options is important to help offer an opportunity for cure and we believe OLYSIO will play a meaningful role in this respect.”