The Medicines Company (MDCO) announced that its intravenous anticoagulant, cangrelor has received an unfavorable recommendation from the U.S. Food and Drug Administration’s (:FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAF).
The company is looking to get cangrelor approved for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) and in patients requiring bridging from oral antiplatelet therapy to surgery. The FDA panel voted against approval of cangrelor for both indications. A response from the FDA on cangrelor’s marketing application is expected by Apr 30.
The negative CRDAC recommendation was not surprising considering that in the briefing document released ahead of the meeting, one of the reviewers was of the opinion that the candidate should not be approved and even suggested that an additional study be conducted.
Issues related to uncertain non-inferiority of cangrelor versus Bristol-Myers Squibb Company (BMY) and Sanofi’s (SNY) Plavix (clopidogrel) and ethical misconduct in the CHAMPION trial were raised. We note that the NDA for the candidate was submitted on the basis of data from four studies – CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE – which evaluated more than 25,000 patients with CAD.
We are disappointed with the panel voting against approval of cangrelor. We believe that chances of cangrelor gaining an outright approval are low. We also remain concerned about cangrelor’s sales potential, on approval, given the stiff competition in the anticoagulant market. The market is also highly genericized.
The Medicines Co. carries a Zacks Rank #3 (Hold). A better-ranked stock is Actelion Ltd. (ALIOF) with a Zacks Rank #1 (Strong Buy).