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BETHESDA, Md. (
) -- An FDA advisory panel meets today to review a new hepatitis C drug from
The Merck drug, known as boceprevir, is one of the most advanced entrants in a new class of oral drugs that acts directly against the hepatitis C virus and promises to radically improve cure rates while cutting treatment duration.
The same panel of FDA-appointed experts reconvenes tomorrow to review
hepatitis C drug telaprevir.
Both boceprevir and telaprevir could be approved and launched later this year, transforming the way hepatitis C is treated and leading to blockbuster sales.
In a preliminary review of boceprevir posted to its web site Monday, the FDA agreed with Merck's clinical data demonstrating that the drug increases cure rates for hepatitis C over standard treatment. The FDA did raise some concerns about boceprevir's safety, including higher rates of anemia and reported psychiatric problems.
The FDA advisory panel will end Wednesday's meeting with a vote on whether to recommend approval of boceprevir. FDA makes the final approval decision. The agency is expected to issue its ruling in early May.
Merck shares closed Tuesday $35.06.
--Written by Adam Feuerstein in Boston.
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