The Japanese approval of the anticoagulant is based on ARISTOTLE, the pivotal Phase 3 trial conducted in 18,201 NVAF patients, which assessed the safety and efficacy of ELIQUIS compared to warfarin.
A subanalysis of the ARISTOTLE study also established a similar safety and efficacy profile of ELIQUIS in Japanese patients, compared to the overall study.
Bristol-Myers Squibb intercontinental region and Japan executive vice president and chief financial officer Charles Bancroft said, "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."
The oral direct Factor Xa inhibitor demonstrated risk reductions against warfarin in three significant outcomes of stroke, major bleeding and all-cause death.
ELIQUIS previously obtained clearance in the European Union and Canada.
Pfizer primary care business unit president and managing director John Young said the Japanese approval is the third regulatory approval for ELIQUIS within six weeks.
"We are excited by this momentum and confident that our combined cardiovascular leadership and expertise with BMS will lead to a successful introduction of this important medicine to patients and physicians in Japan," Young added.