Federal Health reviewers are divided on whether an intravenous blood clot preventer should be approves, Reuters reported.

Dr. Thomas Marciniak, FDA reviewerm recommended the drug, cangrelor, developed by The Medicines Co. not be approved. He said data did not show the product was as good as or superior to a rival drug. However, another reviewer, Dr. Fred Senatore, recommended the drug be approved.

Cangrelor is a drug 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 the intravenous blood clot preventer 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 also 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 said he does not think the drug should be approved because of the way the trial was conducted and the data interpreted. He said that "while the trials did not demonstrate convincingly superiority of cangrelor efficacy, they do demonstrate an increased risk of bleeding with it."

He recommended that the company conduct an additional trial before the drug be considered for approval.

Senatore and another reviewer, B. Nhi Beasley, disagreed. They said the drug met the main goal of the clinical trial and should be approved.

Cangrelor, the intravenous blood clot preventer, 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, The Medcines Co.'s drug is expected to generate sales of about $226 million within four years, according to Thomson Reuters data.