A year after enduring a stinging FDA rejection, the Medicines Company ($MDCO) convinced regulators to change their minds on the blood-thinning cangrelor, winning approval to treat a smaller group of patients after years of development.
The intravenous treatment is now cleared to prevent blood clots in patients with coronary artery disease who need stents to prop open their vessels. About 500,000 people undergo such procedures each year, according to the Centers for Disease Control and Prevention, and the Medicine Company's drug, to be sold as Kengreal, could help reduce rates of heart attack and stroke following stenting.
The approval brings to a close 9 years of Phase III development for cangrelor, a repeatedly failed drug once expected to bring in about $400 million a year at its peak.
Such optimism was in part based on the drug's potential as a bridge therapy for patients awaiting surgery, but, in rejecting the drug, the FDA took serious issue with the Medicines Company's Phase III data on that indication and demanded a new clinical trial before reconsidering. As for the stenting indication, cangrelor significantly beat out Bristol-Myers Squibb ($BMY) and Sanofi's ($SNY) Plavix in improving cardiovascular outcomes in a Phase III trial, but the agency declared the drug unapprovable until the Medicines Company reviewed some data management discrepancies in its application.
Now, cangrelor's long-awaited approval adds to something of a regulatory hot streak for the New Jersey-headquartered Medicines Company.
In May, the FDA signed off on Raplixa, a spray-on sealant designed to stem bleeding during surgery, and Ionsys, a once-abandoned drug-device combo that delivers fentanyl under the skin to treat postoperative pain. Last year, after a 6-year delay, the company won FDA approval for the antibiotic Orbactiv, and the same drug picked up European clearance in March, alongside Raplixa and cangrelor.
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