FDA gives priority review to J&J drug

RARITAN, N.J. — The Food and Drug Administration has given priority review to a drug as a treatment for blood-clot disorders, the manufacturer said Monday.

Johnson & Johnson subsidiary Janssen Research & Development said the FDA had given the priority review status to its applications for Xarelto (rivaroxaban) as a treatment for deep-vein thrombosis — a condition in which clots form in one of the large deep veins, usually in the legs — and pulmonary embolism, which occurs when a DVT clot dislodges and is carried to the lung via the heart.

"We are delighted to have received a priority review designation for Xarelto for the treatment of PE and DVT, and also to proven recurrence of these conditions," Janssen R&D VP and cardiovascular franchise medical leader Paul Burton said.

The FDA grants priority review to drugs that offer major advances in care or treat conditions for which there is no adequate therapy. The company announced that it also would withdraw its approval application for Xarelto as a treatment for stent thrombosis in patients with acute coronary syndrome. The drug already is approved for reducing the risk of clots in the legs and lungs of people who have had knee or hip replacement surgery, and to reduce the risk of hemorrhagic and thrombotic strokes and the clots in people with atrial fibrillation not caused by a heart valve problem.

 


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