Bristol-Myers Squibb and Pfizer receive CHMP backing for new Eliquis indication

Bristol-Myers Squibb and Pfizer have announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended their drug Eliquis for a new indication.

The European Medicines Agency committee has adopted a positive opinion recommending that Eliquis be granted marketing authorisation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults, as well as for the prevention of recurrent DVT and PE.

Data from the pivotal AMPLIFY and AMPLIFY-EXT studies demonstrated the benefits the drug can offer compared to placebo and the current standard of care, with these findings forming the basis of the CHMP's recommendation.

The positive endorsement will now be reviewed by the European Commission, which will soon take a final decision on whether to approve Eliquis for this indication.

Eliquis is already approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It can also be used for the prophylaxis of DVT that can lead to PE in adult patients who have undergone elective hip or knee replacement surgery.

Earlier this year, the CHMP endorsed an addition to the drug's summary of product characteristics, stating that patients can remain on Eliquis while being cardioverted – a procedure to restore normal heart rhythm in patients with arrhythmias.