BETHESDA, Md. (
) -- An FDA advisory panel meets today to review a new hepatitis C drug from
The Vertex drug, known as telaprevir, 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 voted 18-0 Wednesday to recommend approval of a competing hepatitis C drug developed by
Both telaprevir and boceprevir 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 telaprevir posted to its web site Tuesday, the FDA agreed with Vertex's clinical data demonstrating that the drug increases cure rates for hepatitis C over standard treatment. The FDA raised some concerns about rash caused by telaprevir.
The FDA advisory panel will end Thursday's meeting with a vote on whether to recommend approval of telaprevir. FDA makes the final approval decision. The agency is expected to issue its ruling by May 23.
Vertex shares closed Wednesday at $55.54.
--Written by Adam Feuerstein in Boston.
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