Bayer Schering Provides Update On Rivaroxaban

Bayer Schering Pharma has announced that its partner, Ortho-McNeil, does not expect to submit its complete response to FDA until the fourth quarter of this year.

Kemal Malik, member of the Executive Committee and CMO of Bayer HealthCare, said: “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.

“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 US,” he added.

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. FDA has asked the company to submit additional data from completed and ongoing studies of rivaroxaban, and from market surveillance from countries outside the US (where the drug is currently sold to further assess the risk-benefit profile of the drug). FDA also asked for additional information on RECORD study sites, said the company.