FDA panel united against approval of Xarelto

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 - Thumbs down, rejection

An FDA advisory panel voted 10-0 with one abstention against approval of the oral anticoagulant rivaroxaban to reduce the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Janssen Pharmaceuticals had submitted a supplemental new drug application for rivaroxaban (Xarelto) which won FDA approval previously for reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after knee or hip replacement surgery; to reduce the risk of recurrent DVT and PE following initial treatment; and to reduce the risk of stroke in patients with nonvalvular atrial fibrillation.

The FDA repeatedly has given Janssen a cold shoulder in its request for rivaroxaban, a factor Xa inhibitor, in ACS patients after initially giving it a priority review designation. Janssen was proposing that rivaroxaban be used in combination with standard antiplatelet therapy for 90 days. Rivaroxaban has been approved in Europe as a post-ACS treatment.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has voiced concern over possible bleeding risks and missing data in the ATLAS ACS 2 TIMI trial (nti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome). The study evaluated the efficacy of rivaroxaban compared to placebo in preventing cardiovascular death, MI or stroke in patients after an ACS.

Paul Burton, MD, PhD, vice president of clinical development at Janssen Research & Development, said in a release that the company would collaborate with the FDA to address questions raised by panelists.

The FDA will take the panel’s recommendation into consideration when it makes its decision.