Drug major Pfizer Inc. (PFE) on Wednesday, along with Bristol-Myers Squibb Co. (BMY), announced that the Japanese Ministry of Health, Labor and Welfare has approved Eliquis (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation, or NVAF.
Eliquis is an investigational oral anticoagulant discovered by Bristol-Myers Squibb, and in 2007, both companies entered into a worldwide collaboration to develop and commercialize the drug. Atrial fibrillation is the most common cardiac arrhythmia, or irregular heart beat.
"Today's approval of ELIQUIS is the result of our shared vision with Pfizer to introduce a differentiated treatment option to reduce the burden of stroke in patients with nonvalvular atrial fibrillation," said Charles Bancroft, executive vice president, Intercontinental Region and Japan, and chief financial officer, Bristol-Myers Squibb.
According to Pfizer and Bristol-Myers, Eliquis has demonstrated risk reductions compared to warfarin in three important outcomes of stroke, major bleeding and all-cause death.
The companies noted that the latest approval is supported by the pivotal Phase 3 trial, ARISTOTLE, which evaluated the safety and efficacy of Eliquis compared to warfarin in 18,201 patients with NVAF, including 336 patients from Japan.
Subsequent to regulatory approvals in the European Union and Canada, this the third approval for Eliquis for the prevention of stroke and systemic embolism in patients with NVAF, the companies stated.
Further, the companies continue to progress the Eliquis application for stroke prevention in atrial fibrillation in other markets.
On September 26, the U.S. Food and Drug Administration or FDA acknowledged receipt of the Eliquis New Drug Application resubmission to reduce the risk of stroke and systemic embolism in adult patients with NVAF.
Earlier this month, Bristol-Myers and Pfizer announced positive results from a Phase 3 trial that studied Eliquis compared with placebo in patients for the prevention of recurrent venous thromboembolismin. BMY closed Monday's regular trading at $32.46 on the NYSE, while PFE ended at $25.06.
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