The Medicines Company MDCO received encouraging news with the FDA releasing favorable briefing documents ahead of the review by its Cardiovascular and Renal Drugs Advisory Committee related to its platelet inhibitor, Kengreal (cangrelor). The FDA panel is scheduled to review the resubmitted new drug application (NDA) for Kengreal on Apr 15.
The briefing documents contain a recommendation that Kengreal be approved as an adjunct to percutaneous coronary intervention (PCI) for the reduction in risk of periprocedural ischemic complications including myocardial infarction and stent thrombosis in patients in whom treatment with an oral P2Y12 platelet inhibitor prior to PCI is not feasible and when glycoprotein IIb/IIIa receptor antagonists are not likely to be used.
The FDA further noted that while the benefit of Kengreal compared to Bristol-Myers BMY and Sanofi’s SNY Plavix (clopidogrel) is small, the risk is smaller.
We remind investors that The Medicines Co. had received a complete response letter from the FDA for Kengreal in Apr 2014 in response to its original NDA filing. The regulatory agency stated the need to perform additional data analyses from the CHAMPION PHOENIX study.
Last month, Kengreal was approved in the EU (trade name: Kengrexal) making it the first and only intravenous antiplatelet agent for the prevention of platelet activation and aggregation that leads to thrombosis in the acute care setting including patients undergoing PCI.
The regulatory prospects for the U.S. approval of Kengreal are encouraging and might provide The Medicines Co. with another revenue generating product in its portfolio. A final response from the FDA is expected by Jun 23, 2015.
The Medicines Co. carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is AVEO Pharmaceuticals, Inc. AVEO carrying a Zacks Rank #1 (Strong Buy).
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