FDA rejects Xarelto for ACS patients

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The FDA has issued a complete response letter regarding Janssen Research & Development's supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS). Janssen said it is evaluating the complete response letter and will respond to the agency's questions.

"We are confident in the robust study results of the ATLAS ACS 2 TIMI 51 trial and the positive benefit-risk profile of rivaroxaban in patients with ACS. We will continue to work with the FDA to fully address their questions as quickly as possible," said Paul Burton, MD, PhD, vice president, cardiovascular franchise medical leader at Janssen R &D, a subsidiary of Johnson & Johnson.

Janssen R &D submitted this sNDA for ACS patients on Dec. 29, 2011, and received a priority review designation from FDA on Feb. 27. On May 23, the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of rivaroxaban in this indication. The bulk of the day's discussion and debate focused in and around the missing data from the ATLAS ACS trial.

However, at the conclusion of the panel meeting, FDA representatives seemed to leave some room open for further discussion on the fate of rivaroxaban in this patient population, and the company's response to the FDA's letter seems to suggest that it is not giving up the fight, either.

Rivaroxaban is approved for three clinical uses in the U.S.: to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery; to reduce this risk in people who have just had hip replacement surgery; and to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

The sNDA includes results from the pivotal Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) clinical trial of rivaroxaban that were presented at the American Heart Association (AHA) annual scientific sessions in November 2011 and simultaneously published by New England Journal of Medicine.