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New Hepatitis C Drugs Close to Gaining FDA Approval
Date:4/28/2011

THURSDAY, April 28 (HealthDay News) -- Two new drugs that could change the way hepatitis C is treated have been unanimously recommended for approval by a panel of U.S. health experts.

On Thursday, a Food and Drug Administration advisory committee voted 18-0 that telaprevir, made by Vertex Pharmaceuticals Inc., is both safe and effective despite a high rate of rashes that has been reported among those taking it. On Wednesday, the same panel threw its full support behind boceprevir, a new medication from Merck & Co.

Although not required to follow the recommendations of its expert panels, the FDA typically does; a final decision is expected by May 23. The agency convened the two-day meeting to review both drugs, which block the enzyme that allows the hepatitis virus to replicate. Many experts believe that, if approved, boceprevir and telaprevir could revolutionize treatment of hepatitis C-linked disease.

The U.S. Centers for Disease Control and Prevention estimated 17,000 new hepatitis C virus infections in the United States in 2007. Many people with the disease have no symptoms until it has caused liver damage, sometimes so severe that a liver transplant is needed.

Intravenous drug users are particularly susceptible to the disease.

Studies found that when used with two older drugs, boceprevir reduced levels of the virus more effectively than the existing treatments. Merck hopes to sell the medication under the brand name Victrelis, according to Dow Jones.

Debra Birnkrant, director of the FDA's antiviral drugs division, said that both medications appear to increase the cure rate "to more than 30 percent above what we have today," Dow Jones reported.

The new drugs take treatment of hepatitis C in a new direction. Both boceprevir and telaprevir block protease, an enzyme that helps the virus reproduce. The earlier drugs, pegylated interferon and ribavirin, were meant to boost the im
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