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Medicines Co's Cangrelor wins FDA approval after multiple setbacks
2015-07-07         

June 22 (Reuters) - The U.S. Food and Drug Administration approved Medicines Co's (MDCO.O) blood clot preventer Cangrelor on Monday, close to a decade after the drug first entered late-stage studies.

Cangrelor is an intravenous threpay aimed at preventing blood clots in patients who need percutaneous coronary intervention (PCI) or angioplasty - a non-surgical procedure to widen narrowed or obstructed arteries or veins using stents.

Cangrelor is a P2Y12 inhibitor under investigation as an antiplatelet drug[1] for intravenous application. Some P2Y12 inhibitors are used clinically as effective inhibitors of adenosine diphosphate-mediated platelet activation and aggregation. Unlike clopidogrel (Plavix®), which is a prodrug, cangrelor is an active drug not requiring metabolic conversion.Poor interim results led to the abandonment of the two CHAMPION clinical trials in mid-2009. The BRIDGE study, for short term use prior to surgery, continues. The CHAMPION PHOENIX trial was a randomized study of over 11,000 patients published in 2013. It found usefulness of cangrelor in patients getting cardiac stents. Compared with clopidogrel given around the time of stenting, intravenous ADP-receptor blockade with cangrelor significantly reduced the rate of stent thrombosis and myocardial infarction. Reviewers have questioned the methodology of the trial. 

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