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The FDA issued a Complete Response Letter (CRL) to The Medicines Company’s (MDCO - Analyst Report) New Drug Application (NDA) for cangrelor. The company is looking to get cangrelor approved for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients suffering from coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) and in patients requiring bridging from oral antiplatelet therapy to surgery.

The FDA stated that cangrelor cannot be approved at present. The U.S. regulatory body has asked for a series of clinical data analyses of the CHAMPION PHOENIX study for cangrelor’s PCI indication. The FDA also asked The Medicines Co. to review certain processes for data management and provide bioequivalence information on the Bristol-Myers Squibb Company’s (BMY - Analyst Report) Plavix clopidogrel clinical supplies for the CHAMPION studies.

As far as cangrelor’s bridge indication is concerned, the FDA has asked for a prospective, adequate and well-controlled study to evaluate bleeding outcomes. Such a study will provide the required clinical data to determine the benefit-risk profile of the candidate for the bridge indication. The company now intends to work closely with the FDA.

The CRL does not come as a surprise as in February this year the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) had voted against the approval of the candidate. The FDA panel was negative on both the indications. We note that the NDA for cangrelor was submitted on the basis of data from four studies – CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE – which evaluated 25,567 patients with CAD.

Our Take

The CRL on cangrelor comes as a huge disappointment for The Medicines Co. We expect the news to significantly impact the company’s stock price. The Medicines Co. has several pipeline related events in the coming quarters. Similar setbacks will weigh heavily on the stock.

The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Gilead Sciences Inc. (GILD - Analyst Report) and Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report). Both stocks carry a Zacks Rank #1 (Strong Buy).

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