Bristol-Myers Squibb and Pfizer's apixaban has been approved by the FDA to reduce the risk of strokes and blood clots for people with atrial fibrillation. The anticoagulant, however, should not be given to patients with artificial heart valves or those with atrial fibrillation due to heart valve problems, the FDA said. The drug has been approved in Europe.
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 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.
The European Commission approved Eliquis, a factor Xa inhibitor by Pfizer and Bristol-Myers Squibb, to prevent blood clots after hip- or knee-replacement surgery. Later this year, the drugmakers plan to apply for European and U.S. approval of Eliquis' use in patients with atrial fibrillation, a Bristol spokeswoman said.
A study sponsored by Plavix makers Bristol-Myers Squibb Co. and Sanofi-Aventis SA shows that low doses of the anti-clotting drug may suffice as daily treatment in children younger than 2 with heart problems that pose a high risk of blood clots. "We were astonished at how little of the drug they needed to reap the same benefits as adults ... [the findings] show that you can't simply extrapolate from what you do in adults and apply it to children," a pediatric cardiologist said.