New Drug Application for Rivaroxaban in the U.S.: Update on Status of Rivaroxaban Complete Response Letter From U.S. FDA
Bayer Schering Pharma AG, Germany, announced that its partner, Ortho-McNeil, does not expect to submit its complete response to the U.S. food and Drug Administration (FDA) until the fourth quarter of this year, at the earliest.
“We are fully convinced of the positive risk-benefit profile of rivaroxaban, which has been approved in more than 60 countries worldwide in its first indication, and there are no new data in the clinical trials database that would change this assessment,” said Kemal Malik, member of the Bayer HealthCare Executive Committee and Chief Medical Officer. “We want to take the time to diligently respond to all the questions raised by the FDA in the Complete Response Letter and are confident that, together with our partner, Ortho-McNeil, we can provide all information necessary for an approval of rivaroxaban in the U.S.”
While no new clinical or non-clinical studies to evaluate the efficacy or safety of rivaroxaban were requested by the FDA as a pre-requisite for approval, the FDA has asked the company to submit additional data from completed and ongoing studies of rivaroxaban, and from market surveillance from those countries outside the U.S. where the drug is currently sold to further assess the risk-benefit profile of the drug. The FDA also asked for additional information on RECORD study sites.
Additional meetings between Ortho-McNeil and the FDA are planned this summer to agree on a plan to adequately address the points raised by the FDA in its complete response letter. The outcome of those discussions will be a key determinant in establishing the eventual timeline for submission of the complete response.
Rivaroxaban is a novel, oral anticoagulant currently under FDA review as one tablet, once-daily for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery. The NDA for rivaroxaban was submitted by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., on behalf of Ortho-McNeil Inc., on July 28, 2008. In March 2009, an FDA Advisory Committee agreed by a vote of 15-2 that the available clinical data for rivaroxaban demonstrated a favorable risk-benefit profile.
If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.
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