The Japanese Ministry of Health, Labour and Welfare (MHLW) approved Eliquis (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Eliquis is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death.
Eliquis is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the third approval for Eliquis for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, following approvals in the European Union and Canada.
“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 non-valvular atrial fibrillation,” said Charles Bancroft, executive vice president, Intercontinental Region and Japan, and chief financial officer, Bristol-Myers Squibb. “We are confident in the clinical profile of Eliquis and look forward to making this important medicine available to patients in Japan.”
“The approval in Japan marks the third regulatory approval for Eliquis within six weeks,” said John Young, president and managing director, Pfizer Primary Care Business Unit. “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.”
The approval of Eliquis in Japan is supported by the pivotal phase III trial, ARISTOTLE, which evaluated the safety and efficacy of Eliquis versus warfarin in 18,201 patients with NVAF, including 336 patients from Japan. Additionally, the safety and efficacy of Eliquis in Japanese patients were evaluated in a sub-analysis of the ARISTOTLE study, which demonstrated results consistent with the overall study. The application for Eliquis for the prevention of ischemic stroke and systemic embolism was submitted in Japan on December 21, 2011.
The companies continue to progress the Eliquis application for stroke prevention in atrial fibrillation in other markets. On September 26, 2012, The US Food and Drug Administration (FDA) acknowledged receipt of the ELIQUIS New Drug Application (NDA) resubmission to reduce the risk of stroke and systemic embolism in adult patients with NVAF. The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter (CRL) that requested additional information on data management and verification from the ARISTOTLE trial. The FDA Prescription Drug User Fee Act (PDUFA) date is March 17, 2013.
Atrial fibrillation is the most common cardiac arrhythmia (irregular heart beat). The lifetime risk of developing atrial fibrillation is estimated to be approximately 25 per cent for individuals 40 years of age or older. One of the most serious medical concerns for individuals with atrial fibrillation is the increased risk of stroke, which is five times higher in people with atrial fibrillation than those without atrial fibrillation. In fact, atrial fibrillation is responsible for approximately 20 per cent of all strokes in Japan. Atrial fibrillation-related strokes are more severe than other strokes, with an associated 30-day mortality of 24 per cent and a 50 per cent likelihood of death within one year in patients who are not treated with an anti-thrombotic.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize ELIQUIS, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field. Bristol-Myers Squibb and Pfizer will be engaged in providing medical information with proper use of medicines.