Bristol-Myers Squibb Company, Pfizer Inc. Report FDA's Acceptance of Eliquis NDA for Priority Review
by RealPTC Expert
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. Yesterday the companies announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for ELIQUIS(R) (apixaban), an investigational compound for the prevention of stroke and systemic embolism in patients with atrial fibrillation.
As previously disclosed, an application for ELIQUIS for stroke prevention in atrial fibrillation has been validated for review by the European Medicines Agency.
The submissions were based on the results of the ARISTOTLE and AVERROES studies, two Phase 3 trials that evaluated the efficacy and safety of ELIQUIS for the prevention of stroke or systemic embolism in patients with atrial fibrillation.
Subscribe to:
Post Comments (Atom)
0 comments:
Leave a Comment