Feb 10 U.S. Food and Drug Administration
reviewers are divided on whether an intravenous blood clot
preventer developed by The Medicines Co should be
approved, news that sent the company's stock down more than 7
percent on Monday.
Medical Team Leader Dr. Thomas Marciniak recommended the
drug, cangrelor, not be approved, saying data did not show the
product was as good as or superior to a rival drug. Another
reviewer, Dr. Fred Senatore, recommended the drug be approved.
The review, posted on the FDA's website on Monday, came two
days ahead of a meeting of outside experts who will make their
own recommendation. The FDA is not required to follow the
recommendations of its advisors but typically does.
Cangrelor is designed to prevent blood clots during heart
artery-clearing angioplasty and stenting procedures. A clinical
trial of more than 11,000 patients showed those taking cangrelor
had a reduction in the combined risk of death, heart attack,
repeat procedure or stent thrombosis, a blood clot that forms at
the site of the stent.
Patients taking cangrelor had a 22 percent lower risk of
experiencing one of these complications 48 hours after the
procedure than those who took Plavix, a rival product made by
Bristol-Myers Squibb Co. Patients taking cangrelor had a
38 percent reduction in stent thrombosis alone.
Marciniak took issue with the way the trial was conducted
and the data interpreted, and said that "while the trials did
not demonstrate convincingly superiority of cangrelor efficacy,
they do demonstrate an increased risk of bleeding with it."
The trial, known as Champion-Phoenix, followed two failed
trials. For the third trial the company changed the design to
try to differentiate between heart attacks associated with the
drug and those that may have been associated with the procedure.
Marciniak said the company should conduct an additional
trial before the drug be considered for approval.
Senatore and another reviewer, B. Nhi Beasley, on the other
hand, said the drug met the main goal of the clinical trial and
should be approved.
Cangrelor and Plavix, known generically as clopidogrel, had
similar rates of severe bleeding in the trial - 0.16 percent for
cangrelor and 0.11 percent for Plavix.
If approved, cangrelor is expected to generate sales of
about $226 million by 2018, according to Thomson Reuters data.
The Medicines Co's shares were trading $2.53 at $31.69 in
early trading on Nasdaq.