January 23, 2013
Newly Approved Anti-Coagulant Will Be Widely Available by End of Month
Princeton, NJ—Apixaban, the oral anticoagulant newly approved by the FDA to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, is expected to be widely available in the United States by the end of this month, according to Bristol-Myers Squibb (BMS) Company.
BMS and Pfizer Inc. sought approval for the drug, marketed as Eliquis.
“The approval of Eliquis offers patients with non-valvular atrial fibrillation a novel treatment option for reducing the risk of stroke,” said Lamberto Andreotti, BMS chief executive officer. “Eliquis is the result of leading scientific innovation and the shared vision of our alliance to introduce a new oral anticoagulant for patients with non-valvular atrial fibrillation in the U.S.”
Eliquis inhibits Factor Xa, a key blood clotting protein, to decreases thrombin generation and blood clot formation. Unlike widely used warfarin, it does not require routine monitoring using International Normalized Ratio (INR) or other tests of coagulation.
The clinical trial program leading to the drug’s approval was the largest completed clinical development program designed to evaluate risk reduction of stroke or systemic embolism in nonvalvular atrial fibrillation patients. It involved two significant phase III studies—ARISTOTLE and AVERROES—in patients with nonvalvular atrial fibrillation and at least one additional risk factor for stroke. ARISTOTLE compared Eliquis to warfarin in 18,201 patients suitable for warfarin therapy, while AVERROES compared the drug to aspirin in 5,598 patients who were considered unsuitable for treatment with warfarin.
“With a population that is living longer, the prevalence of non-valvular atrial fibrillation is increasing, but many patients are still not being managed effectively with warfarin,” said ARISTOTLE’s lead investigator, Christopher Granger, MD, professor at the Duke Clinical Research Institute at Duke University Medical Center in Durham, NC. “Eliquis represents a significant advance over warfarin for health care professionals to reduce the risk of stroke in patients with non-valvular atrial fibrillation.”
Commenting on behalf of the National Blood Clot Alliance (NBCA), Jack Ansell, MD, chair of the Department of Medicine at Lenox Hill Hospital in New York City, said that “Eliquis demonstrated superiority over warfarin in reducing risks of stroke and blood clots, major bleeding and overall mortality for Afib patients.”
NBCA pointed out that Eliquis is the third new oral anticoagulant to be approved in the last 3 years. Dabigatran etexilate, marketed as Pradaxa by Boehringer Ingelheim Pharmaceuticals, and rivaroxaban, marketed as Xarelto by Janssen Pharmaceuticals, were approved earlier. Unlike warfarin, none of those drugs require routine monitoring or are known to be influenced by diet or many other drugs, the group said.
The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily with reductions necessary for older or smaller patients and those taking certain other drugs. Eliquis was approved with a Boxed Warning for patients who discontinue treatment because of an increased rate of stroke. Prescribing information recommends strong consideration of coverage with another anticoagulant if Eliquis must be discontinued for any reason. Neither patients with prosthetic heart valves nor those with atrial fibrillation caused by a heart valve problem were included in clinical trials and should not take the drug, according to the package information.
The greatest risk, according to the FDA, is the possibility of life-threatening and fatal bleeding, especially since there is no agent that can reverse the anticoagulant effect of Eliquis.
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