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Food and Drug Administration medical reviewers said the agency should approve Effient (prasugrel), a proposed anti-clotting drug being developed by Eli Lilly and Co. and Daiichi Sankyo Co., but should carry tough warnings about bleeding and cancer risks.
Reviews of Prasugrel by different FDA divisions were posted on the agency's Web site Friday.
The drug faces a review Tuesday by medical experts who serve on the agency's cardiovascular and renal drugs advisory committee. The panel is being asked to recommend if prasugrel should be approved for use in certain patients at risk for a heart attack and, if so, what warnings should be placed on the drug.
Last month, a European Medicines Agency committee issued a positive opinion recommending approval of prasugrel. That opinion will be forwarded to the European Commission which grants approval for drugs in the European Union. The commission usually follows that agency's advice.
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