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FDA reviewers mixed on MDCO's cangrelor

February 11, 2014 2:21 AM UTC

The Medicines Co. (NASDAQ:MDCO). The clinical and safety reviewers jointly recommended approval of cangrelor to reduce thrombotic events in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, Thomas Marciniak, medical team leader in FDA's Division of Cardiovascular and Renal Products, recommended against approval.

The two reviewers noted cangrelor plus clopidogrel met the primary composite endpoint of reducing all-cause mortality, myocardial infarction (MI), ischemia-driven revascularization and stent thrombosis at 48 hours vs. clopidogrel alone in the Phase III CHAMPION PHOENIX trial. PHOENIX used a different definition of MI than two previous trials in which cangrelor missed the primary endpoint (see BioCentury Extra, Jan. 8, 2013). ...