Bayer can start selling its novel one-tablet, once daily anticoagulant Xarelto very soon now that European regulators have approved the drug which is being touted as a blockbuster.
Specifically, the European Commission has granted marketing approval for Xarelto (rivaroxaban) for the prevention of venous blood clots in adults undergoing elective hip or knee replacement surgery.
The treatment, a Factor Xa inhibitor, was submitted to the US Food and Drug Administration in July and will be sold by Bayer’s partner Johnson & Johnson. Though getting approval for Xarelto for the prevention of venous thromboembolic events after major orthopaedic surgery of the lower limbs is obviously a boost for Bayer, its prediction of global peak sales of 2 billion euros is dependent on getting to use the drug for stroke prevention in patients with atrial fibrillation. Bayer hopes to win approval for that indication in 2011.
As well as competing with Lovenox, Xarelto has some ground to make up on Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran), an oral direct thrombin inhibitor which was approved in Europe in March for prevention of VTE after hip or knee replacement surgery.
By Kevin Grogan
PharmaTimes
Specifically, the European Commission has granted marketing approval for Xarelto (rivaroxaban) for the prevention of venous blood clots in adults undergoing elective hip or knee replacement surgery.
The treatment, a Factor Xa inhibitor, was submitted to the US Food and Drug Administration in July and will be sold by Bayer’s partner Johnson & Johnson. Though getting approval for Xarelto for the prevention of venous thromboembolic events after major orthopaedic surgery of the lower limbs is obviously a boost for Bayer, its prediction of global peak sales of 2 billion euros is dependent on getting to use the drug for stroke prevention in patients with atrial fibrillation. Bayer hopes to win approval for that indication in 2011.
As well as competing with Lovenox, Xarelto has some ground to make up on Boehringer Ingelheim's anticoagulant Pradaxa (dabigatran), an oral direct thrombin inhibitor which was approved in Europe in March for prevention of VTE after hip or knee replacement surgery.
By Kevin Grogan
PharmaTimes
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