FDA Panel Backs Experimental Merck Hepatitis Drug
WASHINGTON April 27, 2011 (AP)
Federal health experts are recommending approval for a highly anticipated drug from Merck to treat hepatitis C, based on studies showing it cures patients at a higher rate than drugs used for over 20 years.
A Food and Drug Administration panel of experts voted unanimously, 18-0, in favor of Merck's boceprevir tablet as an effective treatment for hepatitis C, which affects an estimated 3.2 million Americans.
The agency is not required to follow the group's recommendation, though it usually does. A final decision is expected mid-May.
On Thursday the panel will review a similar drug from Vertex Pharmaceuticals. Both of the new drugs block the enzyme that helps the hepatitis virus reproduce.
Panelists said the drug is largely safe, but noted side effects including anemia and lower blood cell counts.
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