FDA: OK para Victrelis / Merck para Hepatitis C.

The FDA on Friday approved Merck & Co.'s protease inhibitor Victrelis (boceprevir) for the treatment of hepatitis C, making it the first in a new class of drugs approved to treat the disease. The drug was approved in combination with standard therapy of peginterferon alfa and ribavirin, for use in patients who are treatment naïve or those who have failed to respond to other therapies.

The vote, which follows a positive FDA panel review last month, was based on data from two late-stage studies involving about 1500 adult patients. In both trials, approximately two-thirds of patients given Victrelis in combination with standard care experienced a significantly increased sustained virologic response, compared to standard care alone.

Commenting on the approval, Edward Cox director of the Office of Antimicrobial Products in the agency's Center for Drug Evaluation and Research said "Victrelis is an important new advance for patients with hepatitis C. This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients’ hepatitis C infection compared to currently available therapy."

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