Bayer announced that its development partner Johnson & Johnson expects to respond to the FDA’s complete response letter for the anticoagulant Xarelto (rivaroxaban) in the fourth quarter of this year at the earliest.

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The drugmaker explained that the agency has requested the submission of “additional data from completed and ongoing studies…and from market surveillance from those countries outside the US where the drug is currently sold to further assess the risk-benefit profile” of the compound. Kemal Malik, Bayer HealthCare’s chief medical officer, stated that the companies are confident they can “provide all information necessary.”

Xarelto, which is approved in 60 countries, is under review by the FDA for the prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.

Source: FirstWord

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