Merck/Boceprevir: FDA Hep C Panel "Live Blog" From The Street

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  • Wednesday, April 27, 2011
  • Posted by New HCV Drugs
  • File Under

The streets Adam Feuerstein is live and reporting on Boceprevir which is up for review today by the FDA advisory panel , telaprevir is tomorrow.  Check it out here

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.
You can read the FDA briefing documents here:
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