Eliquis Approval Delayed Until More Drug Trial Information is Given

Posted on June 26, 2012

A blood thinner that could benefit those suffering from a certain heart condition has had its approval delayed for the time being by the Food and Drug Administration.

The drug in question is Eliquis, which is jointly produced by Pfizer and Bristol-Myers Squibb.  The drug aims to reduce the risk of blood clots which lead to stroke in those persons who suffer from what’s known as atrial fibrillation.  Warfarin is a drug that has been used for this purpose for quite some time, but that drug requires extensive follow-up testing to make sure that patients aren’t experiencing a potentially deadly bleeding event.  Plus, warfarin has been shown to have poor reactions with certain other food and drug substances.

Eliquis would theoretically eliminate the dangers of warfarin, with trials showing an 11% decrease in the risk of death and a 31% decrease in the risk of a bleeding injury.  Those persons who used the drug twice in a day had a 21% less likelihood of having a stroke.

The delay in the approval arose because the FDA came to the conclusion that the companies need to provide more details on the verification and data management used during the drug trial presented to regulators.

There are other potential dangers with Eliquis that give some healthcare professionals cause for concern.  Some doctors worry that, though the number of bleeding events is reduced, the events that do take place are more difficult to counteract than those brought about by warfarin.

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