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Reuters Health Information (2011-05-13): U.S. FDA clears new Merck protease inhibitor for hepatitis C

Regulatory

U.S. FDA clears new Merck protease inhibitor for hepatitis C

Last Updated: 2011-05-13 19:31:24 -0400 (Reuters Health)

WASHINGTON/NEW YORK (Reuters) - Merck & Co won U.S. approval on Friday to sell a new drug considered a major advance against the hepatitis C virus.

Boceprevir , which will be marketed as Victrelis, is expected to help transform treatment of the disease with higher cure rates and shorter courses of therapy for some patients.

The FDA approved Victrelis for adults with hepatitis C who were never treated or who failed previous treatments.

Prescribing instructions for Victrelis suggest that some patients with early responses to the drug can stop treatment after 28 weeks, while some others can stop at 36 weeks.

The most common side effects reported with Victrelis were fatigue, anemia, nausea, headache and taste distortion, the FDA said.

Currently, treatment with interferon and ribavirin takes almost a year and often cause flu-like symptoms.

Victrelis must be taken three times a day with food.

The drug label recommends monitoring for anemia.

A similar medicine from Vertex Pharmaceuticals Inc, telaprevir, is poised to win FDA clearance later this month. Both drugs are protease inhibitors.

in Merck's studies, the rate of sustained virologic response with Victrelis reached 66%, an improvement over the 35% to 40% seen with current drugs, but less than the 79% reported for newly treated patients given the Vertex drug, telaprevir.

Approval of Victrelis was widely expected after a Food and Drug Administration advisory panel recommended the drug in an 18-0 vote in April. The Vertex drug also got a unanimous panel recommendation for approval.

Doctors say tens of thousands of patients have been delaying treatment in anticipation of the new medicines, which still must be taken in combination with older hepatitis drugs.

"There are so many patients who are just waiting for a new treatment option. There hasn't been anything new in 10 years," said Dr. Eliav Barr, Merck's head of infectious diseases research.

Dr. Barr said Merck will be ready to begin shipping the drug within the week.

"Victrelis is an important new advance for patients with hepatitis C," Dr. Edward Cox, head of the FDA office of antimicrobial products, said in a statement.

 
 
 
 
                 
 
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