FDA
panel votes in favor of Medicines Co's blood clot preventer
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[April 16, 2015]
By Samantha Kareen Nair and Natalie Grover
(Reuters) - The Medicines Co's intravenous
blood clot preventer can be used in angioplasty procedures, an
independent advisory panel to the U.S. Food and Drug Administration said
on Wednesday.
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The panel voted 9-2 to support the approval of the once-rejected
injection, cangrelor, for use in some patients undergoing
angioplasty, a procedure to widen narrowed or clogged coronary
arteries that often includes the use of stents.
The recommendation follows a review published by FDA staff on
Monday, which supported the approval of the drug.
Cangrelor, which won European approval in March, was rejected by the
FDA in April 2014. In its complete response letter, the agency had
asked the drugmaker to reanalyze data from a pivotal trial called
Champion-Phoenix.
The trial showed that cangrelor was more effective in lowering the
risk of death, heart attack, repeat procedures and stent thrombosis
48 hours after the procedure than Bristol-Myers Squibb Co's Plavix,
known generically as clopidogrel.
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A majority of the panel voted reluctantly in favor of approval,
echoing the views of staff reviewers who concluded that the benefit
of cangrelor was "small" but the risk "smaller" compared to
clopidogrel.
One panel member abstained from voting.
The FDA is not obliged to follow the advice of its advisory panels
but typically does so.
Cangrelor is expected to complement the drugmaker's existing
anticoagulant injection Angiomax, which accounted for more than 80
percent of the company's 2014 revenue of about $724 million.
Earlier this month, the company estimated lower-than-expected
revenue for the Jan-March quarter, with Chief Executive Clive
Meanwell attributing the shortfall to a drop in Angiomax sales due
to potential competition from generic versions.
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"If Angiomax goes away in mid-2015, the incremental impact of
cangrelor becomes less important," Evercore ISI's Umer Raffat said.
He estimates cangrelor will cost $700 per patient and rake in about
$100 million in peak global sales.
The agency is expected to make its decision on cangrelor by June 23,
according to the FDA's staff reviewers.
Trading in the company's stock was halted through the day.
(Editing by Simon Jennings and Saumyadeb Chakrabarty)
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