FDA approves drug for hepatitis C

WASHINGTON, May 23 (UPI) -- The U.S. Food and Drug Administration approved the drug Incivek, or telaprevir, to treat some adults with chronic hepatitis C infection, officials say.

Incivek, marketed by Vertex Pharmaceuticals in Cambridge, Mass., is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to other therapies. The drug is approved for use with interferon therapy made up of peginterferon alfa and ribavirin, the FDA says.

The safety and effectiveness of Incivek was evaluated in three phase 3 clinical trials with about 2,250 adult patients who were previously untreated, or who had received prior therapy.

The sustained virologic response for patients in all three studies treated with Incivek was between 20 percent and 45 percent higher than current standard of care, a statement by the FDA says.

Sixty percent of previously untreated patients achieved an early response after only 24 weeks of treatment compared to the standard of care of 48 weeks. The studies suggest treatment with Incivek can be shortened from 48 weeks to 24 weeks in most patients, the FDA says.

"The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection," Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research.