Medicines Co.’s Drug Fails to Win FDA Panel BackingAnna Edney
Medicines Co.’s experimental drug cangrelor failed to win the backing of U.S. advisers to prevent blood clots in patients undergoing a procedure to unblock heart arteries.
A Food and Drug Administration advisory panel voted 7-2 that cangrelor shouldn’t be approved. Panel members at the meeting in Silver Spring, Maryland, were concerned about the design of the clinical trial comparing the drug to an older anti-clotting medicine. Cangrelor also had higher bleeding rates than the older therapy.
Cangrelor may generate $400 million in sales if approved, Adnan Butt, an analyst at RBC Capital Markets, said in a note to clients on Feb. 7. Almost all of Medicines Co.’s $559 million in revenue in 2012 came from its anticoagulant Angiomax.
Medicines Co.’s shares were halted today because of the meeting. The FDA is expected to decide whether to clear cangrelor for sale by April 30 and doesn’t have to follow the panel’s recommendation,
Medicines Co. had announced it was shelving cangrelor in 2009 after earlier trials showed the therapy wasn’t more effective than other drugs. The Parsippany, New Jersey-based company said last year it found in follow-up studies the therapy significantly outperformed Plavix, a blood thinner from Sanofi and Bristol-Myers Squibb Co., that has lost patent protection and is now in generic forms.