A serious internal disagreement has developed within the FDA over whether to approve the new blood thinner as it stands, sources tell the IN VIVO Blog:
The decision to grant priority review in the first place suggests that the top review managers—namely, Office of Drug Evaluation I director Bob Temple and director of the division of cardio-renal drug products Norman Stockbridge—are excited about the potential for the drug.
However, it appears that another party has made a compelling argument against approval of the application in its current state.
Three issues appear to have impeded an FDA decision: (1) the increase in minor and major bleeding and concerns of related deaths in the prasugrel arm; (2) more cancers discovered in the prasugrel group compared to clopidogrel in the TRITON study; and (3) a recent formulation issue either related to the active ingredient or excipient substance.
Bottom line: A delay until spring next year.
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