Bayer's Xarelto gets EU clearance for PE and prevention of DVT; gives up on Schiff acquisition

Following swiftly on similar news from the US Food and Drug Administration, German drug major Bayer (BAYN: DE) has gained European Commission approval for its oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults. This approval makes rivaroxaban the only novel oral anticoagulant approved in this indication in the European Union.

Xarelto is partnered with Janssen, a unit of Johnson & Johnson (NYSE: JNJ) in the USA, where earlier this month the FDA approved marketing of the drug for the treatment of DVT, PE), ie, leg and lung blood clots, and to reduce the risk of recurrent DVT and PE (The Pharma Letter November 5). The added indication may account for $600 million of a projected $4.2 billion in peak annual sales of the drug in all indications, according to Jeffrey Holford, an analyst at Jefferies Group.

“Approximately one in 10 patients who suffer a pulmonary embolism dies, and concerningly, PE remains a leading cause of hospital death,” said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development, adding:. “This new approval will bring the benefits of Xarelto to more patients and physicians, where the need for a fast, effective and convenient therapy against blood clots is essential for both acute and long-term treatment.”