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J&J files NDA for Bayer's Rivaroxaban

Bayer Healthcare's cooperation partner, Johnson & Johnson Pharmaceutical Research and Development, has filed a new drug application
Bayer Healthcare's cooperation partner, Johnson & Johnson Pharmaceutical Research and Development (J&JPRD), has filed a new drug application (NDA) for novel anticoagulant Rivaroxaban to the US Food and Drug Administration (FDA).

The two companies are hoping that the FDA will approve and indicate the drug for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. In addition to the US NDA, reviews of other filings with regulatory agencies around the world are currently underway

According to Bayer, Rivaroxaban shows superior efficacy over the US approved twice-daily injectable medication, enoxaparin and could be the first novel anticoagulant to be approved in the US in over 50 years.

"Current standards of anticoagulation therapy have limitations and new preventative therapies are needed," said Dr Kemal Malik, member of the Bayer Healthcare executive committee, responsible for product development. "We are now on the cusp of revolutionising the care of patients undergoing hip and knee replacement surgery."

Rivaroxaban was invented in Bayer's Wuppertal Laboratories and is being developed as part of a joint venture between J&JPRD and Bayer Healthcare. If the NDA is successful for US marketing authorisation, Ortho-McNeil - a division of Ortho-McNeil-Janssen Pharmaceuticals, will commercialise the drug.

On July 28, Bayer Schering Pharma UK announced that Rivaroxaban had been recommend for approval for use in the EU by the European Medicine Agency's (EMEA) Committee for Medicinal Products for Human use (CHMP). It is hoped that the European Commission (EC) will grant final approval for the drug within the next few months.

30th July 2008

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