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FDA denies PCI, bridge indications for cangrelor
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The Medicines Company has received a complete response letter from the FDA requesting additional information for the new drug application of its investigational IV antiplatelet agent cangrelor.
The decision follows less than 3 months after the FDA Cardiovascular and Renal Drugs Advisory Committee convened and voted 7-2 against recommending approval of the drug for a PCI indication and unanimously against approval in patients who require an interruption to oral P2Y12 treatment due to surgery.
According to a press release issued by The Medicines Company, the FDA stated that the application for the PCI indication cannot be approved at the present time and recommended that the company “perform a series of clinical data analyses of the CHAMPION PHOENIX study, review certain processes regarding data management and provide bioequivalence information on the clopidogrel clinical supplies for the CHAMPION trials.”
For the bridge indication, the agency stated that a prospective, adequate and well-controlled study in which outcomes such as bleeding are studied, can result in the clinical data necessary to assess the benefit-risk relationship in this indication, according to the release.
The Medicines Company also said that the FDA gave additional comments for the company to address that could affect labeling.
“The next steps of review will focus on additional analyses in response to the FDA. As always, we will work closely with the [FDA] to accommodate their review process,” Clive Meanwell, chairman and chief executive officer of The Medicines Company, said in the release.
Review of the dossier for cangrelor is ongoing with the European Medicines Agency, in Australia and in Switzerland, according to the release.