FDA denies anticoagulant Xarelto, seeking more data

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The FDA has requested more data on Ortho-McNeil-Janssen Pharmaceuticals' rivaroxaban (Xarelto), an oral, once-daily anticoagulant, before it will consider approving the company's new drug application (NDA).

The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development (J &JPRD), on behalf of the Titusville, N.J.-based Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. Rivaroxaban is being jointly developed by J &JPRD and Bayer HealthCare.

J&JPRD and Ortho-McNeil did not specify what data the FDA is seeking, but admitted that the "FDA has not requested that any new clinical or non-clinical studies be conducted evaluating the efficacy or safety of rivaroxaban for this indication as a prerequisite for approval."

Ortho-McNeil said it is currently evaluating the FDA's complete response letter, and will respond to the agency's questions as quickly as possible.

On March 19, the FDA's Cardiovascular and Renal Drugs Advisory Committee agreed by a 15-2 vote that the available clinical data for rivaroxaban demonstrated a favorable benefit-risk profile.

Market analysts have predicted that Xarelto could have blockbuster potential in the chronic indication of stroke prevention in atrial fibrillation, but it will not launch in this indication before 2011. In fact, Xarelto, a successor to 55-year-old blood-thinner warfarin, may generate annual sales of as much as $4 billion, Rick Wise, an analyst who covers J &J for Leerink Swann in New York City, told Bloomberg News.