News | October 01, 2012

FDA Receives Resubmission of the Apixaban Drug Application to Reduce Stroke in Patients With Atrial Fibrillation

Pfizer Bristol-Myers Squibb Eliquis

October 1, 2012 — Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the new drug application (NDA) resubmission for Eliquis (apixaban) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) goal date of March 17, 2013. The FDA has deemed the resubmission a complete response to its June 22, 2012 complete response letter that requested additional information on data management and verification from the ARISTOTLE trial.

The Eliquis NDA is based on the results of the ARISTOTLE and AVERROES studies. These clinical studies evaluated Eliquis in approximately 24,000 patients with NVAF, in the largest clinical trial program conducted to date in this patient population. The landmark ARISTOTLE trial compared apixaban to warfarin, the standard of care, in more than 18,000 NVAF patients, while AVERROES compared apixaban to aspirin in 5,598 NVAF patients who were unsuitable for vitamin K antagonist (VKA) therapy.

ARISTOTLE and AVERROES are part of an ongoing clinical development program for Eliquis, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of nine completed or ongoing, randomized, double-blind phase III trials.

The companies continue to progress the Eliquis application for stroke prevention in atrial fibrillation in markets outside of the United Stated, including the European Union and Japan, based on the ARISTOTLE and AVERROES studies. On Sept. 21, 2012, Bristol-Myers Squibb and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that Eliquis (apixaban) be granted approval for the prevention of stroke and systemic embolism in adult patients with NVAF and with one or more risk factors for stroke.

Eliquis is also being investigated in Phase III trials for the treatment of venous thrombolembolic events (VTE).

For more information: www.pfizer.com

Related Content

Vascepa Markedly Reduces First, Repeat and Total Cardiovascular Events
News | Pharmaceuticals | March 29, 2019
Taking a high dose of icosapent ethyl significantly reduces the occurrence of first, subsequent and total ischemic...
Bempedoic Acid Combination Tablet Significantly Lowers LDL-Cholesterol

Image courtesy of Esperion

News | Pharmaceuticals | March 25, 2019
Phase 3 results from Study 2, also known as CLEAR WISDOM, of bempedoic acid were recently presented at the American...
Aurobindo Pharma Adds to Nationwide Valsartan Blood Pressure Medication Recall
News | Pharmaceuticals | January 10, 2019
January 10, 2019 — Aurobindo Pharma USA Inc.
Mylan Expands Nationwide Recall of Valsartan Blood Pressure Medication
News | Pharmaceuticals | December 11, 2018
December 11, 2018 — Mylan Pharmaceuticals is expanding its consumer-level voluntary nationwide recall to include all
Farxiga Reduces Heart Failure Hospitalization, Cardiovascular Death for Type 2 Diabetes
News | Pharmaceuticals | November 15, 2018
AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for...
Vascepa and Statins Significantly Reduce Cardiovascular Events in the REDUCE-IT trial. #AHA #AHA18 #AHA2018
News | Pharmaceuticals | November 13, 2018
A study in the current edition of the New England Journal of Medicine shows that a particular treatment significantly...
Evolocumab Benefits High-Risk Patients With Established Cardiovascular and Chronic Kidney Disease
News | Pharmaceuticals | October 31, 2018
Amgen announced a new Repatha cardiovascular outcomes study (FOURIER) analysis evaluating the effects of Repatha (...
Jardiance Improves Life Expectancy for Adults With Type 2 Diabetes and Cardiovascular Disease
News | Pharmaceuticals | October 11, 2018
Novel results from the landmark EMPA-REG OUTCOME trial suggest that treatment with Jardiance positively impacts life...
Effect of Daily Aspirin on First-Time Heart Attack and Stroke Risk Inconclusive
News | Pharmaceuticals | September 04, 2018
The jury is still out on whether people at moderate risk of a first heart attack or stroke should take daily aspirin to...
Overlay Init