Bayer files Xarelto for pulmonary embolism in Europe

Bayer has filed for approval of its oral anticoagulant Xarelto in the EU for the initial treatment of pulmonary embolism (PE), potentially opening up a new market valued at up to $1bn for the drug.

Xarelto (rivaroxaban) has been submitted for the initial treatment of PE, as well as the long-term prevention of deep vein thrombosis (DVT) and PE in adults, based on the results of the EINSTEIN-PE study.

The trial showed that Xarelto was as good as low-molecular weight heparin (LMWH) followed by warfarin in preventing PE patients from developing a secondary venous thromboembolism, and also cut the risk of major bleeds such as intracranial haemorrhage by 50 per cent.

"In the EINSTEIN-PE study we demonstrated that rivaroxaban is the first oral single-drug solution for the initial treatment of PE and long-term prevention of recurrent venous thromboembolism," said Dr Kemal Malik, Bayer's head of global development.

Most other studies have treated all patients with LMWH in the initial treatment phase, and made a comparison between a new anticoagulant and warfarin only in the maintenance phase.

However, the EINSTEIN-PE study compared the oral single-drug approach of rivaroxaban 15mg twice daily for three weeks, followed by 20mg once daily for maintenance, with subcutaneous enoxaparin followed by warfarin, the current standard of care.

Xarelto is already marketed in Europe for VTE prevention in adults undergoing surgery for hip or knee replacement, and also for the prevention of stroke and systemic embolism in patients with atrial fibrillation as well as for the treatment of DVT and the prevention of recurrent DVT and pulmonary embolism following an acute DVT in adult patients.

Bayer achieved €86ms ($112m) in Xarelto sales in 2011, with approval for many of the new indications coming too late in the year to have a material impact. It has previously said it expects the drug to achieve more than €2bn ($2.6bn) a year in peak sales.