The FDA issued a Complete Response Letter (CRL) to
The Medicines Company
) 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.
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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
) 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.
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.
Alexion Pharmaceuticals, Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).