Medicines Co. jumped the most in almost a month after Food and Drug Administration staff recommended the company’s intravenous blood clotting drug for approval.
The stock rose as much as 6.6 percent following an FDA staff report released Monday that said Kengreal should be approved for patients undergoing procedures to open blocked arteries.
Medicines Co. is seeking Kengreal’s approval as an alternative to other clot preventers such as clopidogrel, the generic version of Bristol-Myers Squibb Co.’s Plavix. Kengreal would be used to reduce the risks of heart attack and blood clots in patients who’ve had a procedure to open a blocked artery and who can’t take a pill.
The stock rose 3.3 percent to $29.25 at 12:26 p.m. in New York, after earlier rising to as much as $30.17.
The FDA had originally rejected Kengreal in April 2014, asking Medicines Co. to do more analysis of its clinical trial data and resubmit the drug. In Monday’s report, FDA staff said that the “study as a standalone trial was sufficient to warrant approval.”
A body of outside advisers to the FDA will meet Wednesday to discuss whether the benefit of Kengreal outweighs the increased risk of bleeding compared to clopidogrel. The FDA is scheduled to rule on the application by June 23.
Medicines Co.’s biggest product is Angiomax, another anticlotting drug, which sold $636 million last year. The Parsippany, New Jersey-based drugmaker said on April 9 that sales of Angiomax could fall this year if a generic version of the drug becomes available in the U.S. in June.