FDA vote is divided over approval of new blood clot preventing drug

FDA vote is divided over approval of new blood clot preventing drug

A new drug has divided the FDA.

Reviewers for the Food and Drug Administration are divided on whether or not to approve an intravenous blood clot preventive named cangrelor, developed by The Medicines Co.

In a report posted on Monday, Feb. 10, Medical Team Leader at the FDA’s Center for Drug Evaluation, Dr. Thomas Marciniak urged that cangrelor not be approved, explaining that there was not enough evidence to prove that the drug would be more effective than its current competitor, while DRs. Fred Senatore and Nhi Beasley suggested that the drug be approved, explaining that cangrelor could be beneficial in providing reduced risks for individuals undergoing Percutaneous Coronary Intervention, or PCI.

The drug is designed to prevent blood clots during certain medical procedures. Cangrelor was tested on a sample of more than 11,000 patients and results showed that patients taking cangrelor versus competitor brand Plavix, had a 22 percent lower risk of experiencing complications such as heart attack, repeat procedure, stent thrombosis, or death, 48 hours after surgery.

While the trial deemed itself successful over its competitor, these results came only after two previous trials of the drug which had both failed. Marcianak stressed the importance of The Medicines Co conducting another trial before the approving the drug, a view that not all reviewers supported.

The Medicines Co, which suffered a 7 percent decrease in stock on Monday, Feb. 10, after the report came out, would generate an estimated $226 million in sales by 2018, if cangrelor is approved, according to data produced by Thomson Reuters.

While Marcianak stands firm on his opinion that further trials must be initiated before approval of the drug can be made, other reviewers believe that the drug fulfilled the goals of the trial. The report, which came out on Monday, was published two days prior to a meeting which is to be held among experts outside of the FDA. Though the FDA is not required to vote based on the recommendation of its advisors, it historically has.


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