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Home Industry News Bayer awaits European approval for Xarelto

Bayer awaits European approval for Xarelto

2nd November 2007

Bayer Healthcare is awaiting approval for Xarelto from the European Agency for the Evaluation of Medicinal Products (EMEA) following its submission of a Marketing Authorisation Application to the agency.

Xarelto (rivaroxaban) is a once-daily Factor Xa inhibitor indicated for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery of the lower limbs.

Ahead of the EMEA submission, data from Record3 studies was presented which demonstrated that Xarelto can significantly reduce the risk of VTE in patients undergoing total knee replacement surgery compared with enoxaparin.

Dr Kernal Malik, head of global development at Bayer, described the data submission as a “milestone” in the development of the treatment, which is intended to prevent life-threatening blood clots.

“As an effective and convenient, once-daily oral treatment with a reassuring safety profile, we feel confident that rivaroxaban has the potential to set a new standard of care in the preventative treatment of thrombosis in patients undergoing major orthopaedic surgery,” he added.

The Marketing Authorisation Application was based on data from three Phase III studies which saw over 10,000 patients enrol.

Also this week, Bayer and Onyx Pharmaceuticals announced that their Nexavar tablets for the treatment of patients with heptacellular carcinoma have received marketing authorisation from the European commission.

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