NAPSR News: Eliquis has been approved by the FDA for Three New Indications

WASHINGTON - Aug. 22, 2014 - PRLog -- Pfizer and Bristol-Myers Squibb have announced FDA approval of a Supplemental New Drug Application (sNDA) for Eliquis to treat  DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Eliquis (apixaban) is an oral selective Factor Xa inhibitor (Factor Xa is a key blood-clotting protein) which decreases thrombin generation and blood clot formation.

“We are pleased that Eliquis is now available as an effective treatment option for DVT and PE,” said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. “Eliquis offers oral dosing, no routine coagulation testing, and does not require the use of a parenteral anticoagulant or bridging during initiation.”

“DVT, which may lead to PE, can be a serious medical condition, with PE requiring immediate medical attention for treatment. Once a VTE has occurred, approximately 33 percent of patients are at risk of a recurrence within 10 years,” said Steve Romano, senior vice president, Head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc. “The Bristol-Myers Squibb and Pfizer alliance is committed to delivering important treatment options to patients and physicians.”

FDA approval was based on the global studies AMPLIFY and AMPLIFY-EXT. The AMPLIFY study, a randomized, double-blind trial evaluated the efficacy and safety of Eliquis to treat DVT and PE patients including those with confirmed symptomatic DVT or PE. Based on the trial conducted 2,609 patients were treated with Eliquis and 2,635 received standard of care (initial enoxaparin treatment for at least five days, overlapped by warfarin therapy [International Normalized Ratio (INR) range 2.0-3.0] orally for six months)

According to the data, patients who received Eliquis 10 mg twice daily for one week followed by 5 mg twice daily for six months demonstrated efficacy comparable to standard of care for the primary efficacy composite endpoint of recurrent, symptomatic VTE, or VTE-related death.

-Eliquis demonstrated superiority in the primary safety endpoint of major bleeding versus standard of care.

-For the secondary safety endpoint, clinically relevant nonmajor bleeding (CRNM) were fewer in Eliquis-treated patients compared to standard of care-treated patients

-The discontinuation rate due to bleeding events was 0.7% in the Eliquis-treated patients compared to 1.7% in enoxaparin/warfarin-treated patients.

Eliquis is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the US and sales of Eliquis are expected to see a boost based on the expanded indications.

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