June 28th, 2013

FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of rivaroxaban to treat ACS patients.

Both sNDAs were based on the  pivotal ATLAS ACS 2-TIMI 51 trial. Initially the trial was widely praised, leading to expectations that rivaroxaban would be the first anticoagulant to receive an ACS-related indication. But the enthusiasm evaporated when FDA reviewers raised concerns about the trial and when the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against the ACS indication. (Diverging from their U.S. colleagues, European regulators granted the general ACS indication for rivaroxaban in May.)

“We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA,” said a company official.

Rivaroxaban is currently approved to reduce the risk of blood clots following knee and hip replacement surgery, for stroke prevention in people with nonvalvular atrial fibrillation, and for the treatment of and to prevent the recurrence of pulmonary embolism and deep vein thrombosis.


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