Bayer’s Xarelto recommended for EU atrial fibrillation approval

Bayer has announced that its oral Factor Xa inhibitor Xarelto has been recommended for approval in a new indication in Europe.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on a label update regarding the use of once-daily Xarelto in combination with a P2Y12 inhibitor for the treatment of patients with non-valvular atrial fibrillation. 

This would allow the drug to be administered to patients who require oral anticoagulation and undergo percutaneous coronary intervention with stent placement, with a final decision from the European Commission expected by the end of this year.

Data from the phase IIIb PIONEER AF-PCI study helped to support this decision, with the trial demonstrating significantly reduced rates of clinically significant bleeding with Xarelto compared with VKA in patients who require oral anticoagulation.

Dr Michael Devoy, head of medical affairs and pharmacovigilance of Bayer's pharmaceuticals division and the company's chief medical officer, said: "The recommendation by the CHMP is an important step towards improved management of these patients, who are at high risk of thrombosis and need anticoagulation therapy because they have atrial fibrillation and received a stent placement."

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