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Home Industry News Bayer announces EU approval recommendation for rivaroxaban

Bayer announces EU approval recommendation for rivaroxaban

28th July 2008

Bayer has announced that its novel anticoagulant Xarelto (rivaroxaban) has been recommended for approval in the European Union (EU) for the prevention of venous blood clots in patients who have undergone elective hip or knee replacement surgery.

Following the receipt of this opinion from the Committee for Medicinal Products for Human Use (CHMP), the company expects final approval will be given by the European Commission within the next few months.

Xarelto received the positive opinion following the review of three Record trials involving 10,000 patients undergoing elective knee or hip replacement surgery.

The compound was discovered by Bayer in its Wuppertal laboratories in Germany and is being developed by the company in conjunction with Johnson & Johnson Pharmaceutical Research & Development.

Dr Kemal Malik, member of the Bayer HealthCare executive committee responsible for product development, said: “The recommendation for approval of rivaroxaban by the CHMP marks another significant milestone in our extensive development program.”

He added this opinion was received nine months after submission of the compound for approval, a speedy turnover compared to the average.

Last month, Bayer announced the results of the Record studies at the International Congress on Thrombosis in Athens.

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