|The Medicines Company CEO Clive Meanwell|
European regulators are recommending approval for The Medicines Company's ($MDCO) cangrelor, setting up an overseas nod for a blood-thinning drug rejected by the FDA last year.
The drug 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 European Medicines Agency is recommending cangrelor be used only in patients who can't take generic P2Y12 inhibitors like Plavix, a smaller indication than the company initially sought.
Such a recommendation, handed down by the EMA's Committee for Medicinal Products for Human Use (CHMP), generally results in a full European approval within about three months.
The European success for cangrelor, to be marketed as Kengrexal, is part of a big day for The Medcines Co. The CHMP also recommended the antibiotic oritavancin, approved in the U.S. last year as Orbactiv, and the surgical sealant Raplixa, whose FDA application is under review.
"At a time of increasing interest in hospital-based innovation worldwide, products designed to address significant unmet needs in acute and intensive hospital care and which offer potential efficiencies of hospital performance do not come to market too often," CEO Clive Meanwell said in a statement. "To have three positive opinions on the same day for products which have the potential to improve hospital outcomes is remarkable."
The Medicines Co. hasn't found similar luck in its home country, however, as the FDA shot down cangrelor's application in May over checkered efficacy results and missing data. The company pitched its drug for use both as an adjunct to stenting and as a bridge therapy for patients who need bypass surgery. On the former indication, the FDA instructed The Medicines Company re-analyze the data from its 11,145-patient Phase III program, and on the bridge indication, the agency requested an entirely new prospective study, putting off approval indefinitely.
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