Bristol-Myers Squibb and Pfizer’s Eliquis receives new EU approval

Bristol-Myers Squibb and Pfizer have received European Commission approval for a new indication of their anticoagulant therapy Eliquis.

The drug has been approved for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prevention of recurrent DVT and PE.

It is also approved for the prevention of venous thromboembolism in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation with one or more risk factors.

This new approval follows a recommendation from the Committee for Medicinal Products for Human Use and was supported by evidence from the pivotal phase III trials Amplify and Amplify-EXT.

Dr Elliott Levy, senior vice-president and head of specialty development at Bristol-Myers Squibb, said: "Every year, approximately one million patients in the EU are diagnosed with VTE. Once a VTE has occurred, approximately 33 percent of patients may experience a recurrence within ten years."

This comes after the firms commenced a phase IV trial assessing the performance of Eliquis in the treatment of patients with nonvalvular atrial fibrillation undergoing cardioversion last month.