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.You can read the FDA briefing documents here:
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.
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