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Positive opinion for Bayer drug

The European Committee for Medicinal Products for Human Use has recommended the approval of rivaroxaban, an anticoagulant being developed and researched by Bayer Schering Pharma UK
The European Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of rivaroxaban, an anticoagulant being developed and researched by Bayer Schering Pharma UK.

The company hopes that the European Commission (EC) will grant final approval for the drug within the next few months providing marketing authorisation for all 27-member states. Rivaroxaban, which is known by its brand name Xarelto, is an anticoagulant developed for the prevention of venous blood clots - deep vein thrombosis (DVT) and pulmonary embolism (PE) - in patients undergoing elective hip or knee replacement surgery.

Recommendation for the drugs approval came just nine months after Bayer Schering Pharmaís submission and was based on results for the phase III Record clinical trials into rivaroxaban. According to Bayer Schering Pharma, the studies, which involved 10,000 patients undergoing elective hip or knee replacement surgery, demonstrated the drugs effectiveness over other medicines.

"The prevention and treatment of thrombosis remains a challenge for patients requiring chronic therapy. The availability of agents such as rivaroxaban has the potential for a substantial impact on patient care," said Ajay Kakkar, professor of surgical sciences at Barts and the London School of Medicine.

28th July 2008

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