The Medicines Company’s Kengreal Gets FDA Support After Previous Setbacks
April 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) announced today that after reanalysis of data for The Medicines Company ’s blood thinner Kengreal (cangrelor), they backed the drug for approval.
Kengreal is a blood thinner that The Medicines Company, headquartered in Parsippany, N.J., was testing for the reduction of thrombotic events such as stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) and to maintain blood clotting levels in patients who came off medications because of surgery. In April 2014 the FDA rejected the compound because of problems with the company’s pivotal trial, called Champion-Phoenix. As a result, the FDA requested the company reanalyze its data. The study looked at more than 11,000 patients and found that the drug cut the risk of death, heart attack, repeat procedures and stent thrombosis, which is blood clotting at the site of a cardiac stent.
The data indicated that patients on Kengreal were 22 percent less likely to have those complications 48 hours after the stent procedure than patients who were given Bristol-Myers Squibb Company 's competitive product, Plavix (clopidogrel). The FDA report indicated that “the Phoenix-study as a stand-alone trial was sufficient to warrant approval of cangrelor.”
The primary change in the recent evaluation of the study was to differentiate between heart attacks associated with Kengreal and heart attacks that may have been caused by the angioplasty itself. The conclusion of the FDA is that Kengreal is slightly better than Plavix and similar products because of its fast action and how quickly it is cleared by the patient’s metabolism—within one hour, compared to up to five days for other drugs.
On Mar. 30, 2015 the company announced that Kengrexal (cangrelor), had been granted marketing approval by the European Commission to sell the drug in Europe. Approval had also been granted in Europe for Orbactiv, a single-dose intravenous antibiotic for skin infections and Raplixa, a powdered fibrin sealant that is used to stop bleeding in a variety of settings.
“The EEA includes a population of more than 500 million people,” said Clive Meanwell, chair and chief executive officer of The Medicines Company in a statement. “Securing market authorization for these three acute care treatments opens the door for us and our partners to potentially improve patient care for many patients in European hospitals.”
The company’s stock has been on a roller coast ride the last year, with a low of $20.36 on Oct. 13, 2014 and a high of $31.29 on Mar. 19, 2015. It dropped recently on April 2 to 27.52, but is currently selling for $29.82. It was noted that Meanwell sold 16,667 shares of company stock on the open market on April 1 for an average sale prices of $27.58.
The company did not respond to requests for a statement.