Earlier in July 2008, Bayer’s partner Johnson & Johnson filed for the approval to market Rivaroxaban. FDA has not requested any new clinical or non-clinical studies to be conducted for evaluating the efficacy or safety of Rivaroxaban, for this indication as a pre-requisite for approval.
However, Bayer is confident in the positive benefit-risk profile of Rivaroxaban, saying the questions raised by the FDA can be promptly addressed. Kemal Malik, Member of the Executive Committee and Chief Medical Officer at Bayer, said: “Together with our development partner, we are evaluating the letter and we will promptly address FDA’s questions.”
If approved by the FDA, Ortho McNeil, a division of Ortho McNeil-Janssen Pharmaceuticals, a Johnson & Johnson company, will commercialize Rivaroxaban in the US and Bayer HealthCare will be responsible for the marketing of Rivaroxaban in countries outside the US.