After an uncommonly bipolar review from FDA staff, The Medicines Co.'s ($MDCO) cangrelor got an icy reception from a panel of agency advisers, who voted against granting approval for the company's blood-thinning treatment.
In a 7-2 decision, the FDA's cardio drug committee recommended against cangrelor, an injection designed to prevent blood clots in patients undergoing stenting procedures. The agency is expected to make a final decision on the drug by April 30, and while it is is not required to follow the votes of its advisers, it usually does
The panel's vote comes on the heels of some diametric advice from FDA reviewers. Earlier this week, agency investigator Thomas Marciniak ripped cangrelor's pivotal data, saying the drug failed to prove better at preventing clots than Bristol-Myers Squibb's ($BMY) Plavix and only increased bleeding rates, suggesting The Medicines Co. undertake another trial to sort things out. Within the same document, however, another FDA reviewer opined that cangrelor met its goals in the submitted study and should be approved.
FDA advisers have now sided with the former take, and their vote casts some serious doubt over the fate of a drug once predicted to bring in as much as $400 million a year at its peak.
"Although we are disappointed by the committee's decision, we appreciate the dialogue during today's meeting and look forward to subsequent discussion with the FDA," CEO Clive Meanwell said in a statement. "We continue to believe in the safety and efficacy of cangrelor and look forward to working with the agency as it completes its review."
In the pivotal data under review, Parsippany, NJ-based The Medicines Co. 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 the old pill, and The Medicines Co. briefly gave up on cangrelor before embarking on its latest late-stage effort.
- read the statement