The FDA has approved the use of Bristol-Myers Squibb and Pfizer's Eliquis, or apixaban, for the treatment of patients who are at risk for or already suffering from deep vein thrombosis and pulmonary embolism. The drug was previously cleared for use in atrial fibrillation patients who have a risk of stroke or dangerous clots.
Bristol-Myers Squibb and Pfizer received approval from the European Commission to market their anti-clotting drug Eliquis, or apixaban, for stroke and blood clot prevention in patients with atrial fibrillation. The OK is Eliquis' first for the indication. The FDA is expected to decide on an application for the same condition by March 17.
The Committee for Medicinal Products for Human Use issued a positive opinion for Pfizer and Bristol-Myers Squibb's anti-clotting drug Eliquis, or apixaban, to prevent systemic embolism and stroke in patients with nonvalvular atrial fibrillation and risk factors for stroke. The European Commission will review the opinion and decide on approval.
The FDA granted priority-review designation to Pfizer and Bristol-Myers Squibb's Eliquis, or apixaban, and is expected to decide on the anti-clotting drug by March 28.
The drugmakers aim to launch Eliquis for stroke prevention among patients with atrial fibrillation. If approved, Eliquis will be the third such treatment, after Bayer and Johnson & Johnson's Xarelto and Boehringer Ingelheim's Pradaxa.
Bristol-Myers Squibb and Sanofi-Aventis have obtained the European Medicines Agency's endorsement to use anti-clotting drug Plavix for the prevention of thromboembolic and atherothrombotic events in certain adults with atrial fibrillation.