Regulatory

FDA approves oral simeprevir (Olysio) for hepatitis C

Last Updated: 2013-11-25 13:40:21 -0400 (Reuters Health)

(Reuters) - U.S. regulators late Friday approved Johnson & Johnson's oral protease inhibitor Olysio (simeprevir) for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen.

Efficacy was demonstrated in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis, the company said.

Olysio may benefit patients with chronic hepatitis C, including those who are treatment naive or who have failed prior interferon-based therapy.

Hepatitis C affects about 3.2 million Americans, killing more than 15,000 each year, mostly from illnesses such as cirrhosis and liver cancer.

For treatment-naive and prior-relapser patients, a fixed treatment regimen of 12 weeks of Olysio combined with 24 weeks of pegylated interferon and ribavirin is recommended, the company notes. For prior partial- and null-responder patients, a treatment regimen of 12 weeks of Olysio combined with 48 weeks of pegylated interferon and ribavirin is recommended.

"Given the complexity of the condition, Olysio was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments," Dr. Douglas Dieterich, Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, and Olysio clinical trial investigator, said in a company statement.

He called the approval of Olysio "an important milestone for people living with chronic hepatitis C as it means that patients have a new treatment option with the potential to cure this challenging disease."

Olysio is a member of the same class of drugs as Merck & Co's Victrelis (boceprevir) and Vertex Pharmaceuticals' Incivek (telaprevir). The FDA approved both those drugs in 2011.