FRIDAY, SEPTEMBER 30, 2016

Janssen Therapeutics receives approval for hepatitis C medication

Janssen Therapeutics announced on Friday that it received approval from the United States Food and Drug Administration for OLYSIO, a treatment for chronic hepatitis C and NS3/4A protease inhibitor.

The drug is part of an antiviral treatment regimen that includes pegylated interferon and ribavirin for genotype 1 infected adults with compensated liver disease, including cirrhosis.

Chronic hepatitis C is a blood-borne infection of the liver that affects approximately 3.2 million people in the U.S. The new drug is a prescription medication that blocks a viral protease enzyme, which allows the hepatitis C virus to reproduce inside cells.

"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," Douglas Dieterich, a professor of medicine in the Mount Sinai School of Medicine Division of Liver Diseases and OLYSIO clinical trial investigator, said. "The FDA approval of OLYSIO is 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."

Results from tests on treatment-naive patients receiving OLYSIO showed 80 percent were cured, or reached sustained virologic response, 12 weeks after treatment. Of the patients in the placebo group, 50 percent reached sustained virologic response.

"As an advocate working with the hepatitis C community, I'm pleased to know that Janssen has been working to make sure OLYSIO will be reasonably priced and available to the patients who need it," Sue Simon, the president of the Hepatitis C Association, said. "It is notable that in addition to introducing a new treatment option for patients, Janssen is establishing comprehensive programs to support and assist patients in their treatment journey."