The FDA issued a complete response letter regarding the application for approval of Xarelto (rivaroxaban), and requested more information, Bayer and its US development partner Johnson & Johnson announced on Thursday.

The companies remarked that the agency did not request any new clinical or non-clinical data on the safety or efficacy of the drug as a condition for obtaining approval in the requested indication of preventing deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

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The companies indicated that they are evaluating the letter and will address the FDA’s questions as quickly as possible. Executives from the drugmakers added that they are “confident in the positive benefit-risk profile” of the anticoagulant. Leerink Swann & Co. analyst Rick Wise commented that: “Our impression is that the questions are not very onerous and the company expects to submit a response as quickly as possible. We had anticipated a potential delay in Xarelto approval, and this complete response letter has no material impact to our current estimates.” Wise forecast the drug could generate annual sales of as much as $4 billion, if approved.

The news of the FDA’s rejection follows an advisory panel meeting in March, where committee members voted 15 to 2 that available clinical data demonstrated that the drug’s benefits outweighed its risks.

Source: FirstWord

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