A panel of FDA advisers reversed its earlier derision and voted in favor of The Medicines Company's ($MDCO) long-delayed blood thinner, spelling a likely approval for the drug after years of setbacks.
The treatment, cangrelor, is an intravenous therapy used to prevent blood clots in patients with coronary artery disease who need stents, designed to ward off strokes after the devices are installed. The agency's independent cardio committee voted 9-2 with one abstention in favor of recommending the drug for approval, satisfied the company addressed some lingering concerns tied to its 11,145-patient Phase III program.
The FDA is not required to follow the votes of its advisers, though it commonly does, and the agency is slated to hand down a final decision on cangrelor by June 23.
The panel's change of heart follows a stinging 2014 rejection in which the committee pilloried The Medicines Company's pivotal program, taking issue with how the company analyzed its Phase III data and threw out cangrelor's case for use as a bridge therapy for those undergoing surgery. To sway regulators, the company reanalyzed the data in question and narrowed its ambitions, curtailing its intended indication to patients who can't handle standard platelet inhibitors.
An approval would bring to a close 9 plodding years of Phase III development for cangrelor, a drug once expected to bring in about $400 million a year at its peak. The market has changed in the ensuing years, however, and evolving standards of care coupled with cangrelor's likely narrow indication put it in line for just $100 million in peak annual sales, according to Evercore ISI's Umer Raffat.
The company convinced European regulators to approve cangrelor last month, marketing the drug Kengrexal.
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