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.
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.
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.
“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)
Source: Reuters Health