Following the advice of its advisers, the FDA has rebuffed cangrelor, a blood-thinning drug from The Medicines Company ($MDCO), asking for more analysis and a new study before it'll give the treatment a second chance.
The drug is an intravenous therapy used to prevent blood clots in patients in need of stents, designed to treat those undergoing coronary interventions and function as a bridge therapy for those undergoing surgery. On the former indication, the FDA instructed The Medicines Company to conduct a series of data analyses on its 11,145-patient Phase III program, reviewing its processes and double-checking clinical supplies. On the bridge indication, however, the agency requested an entirely new prospective study, after cloudy results from a 210-patient trial left the drug's risk-benefit profile unclear.
Cangrelor's rejection comes as little surprise after the drug received a scathing review from FDA staff and a negative vote from a panel of FDA advisers in February. In a 7-2 decision, the FDA's cardio drug committee recommended against approving the treatment, questioning the design, oversight and conduct of its Phase III program.
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| The Medicines Company CEO Clive Meanwell |
"The next steps of review will focus on additional analyses in response to the FDA," The Medicines Company CEO Clive Meanwell said in a statement. "As always, we will work closely with the agency to accommodate their review process."
In the pivotal data submitted, Parsippany, NJ-based The Medicines Company tested cangrelor in more than 11,000 patients undergoing percutaneous coronary intervention, finding that its drug demonstrated a 22% reduction in risk of serious adverse events compared to Plavix. However, that study followed two other Phase III efforts in which the intravenous treatment failed to beat out standard of care, and The Medicines Company briefly gave up on cangrelor before embarking on its latest late-stage effort.
- read the statement