FDA advisory panel nixes approval of J&J and Bayer’s Xarelto for wider use

The US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee has voted against the approval of the use of Xarelto (rivaroxaban) in an additional indication filed for by US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development unit under its partnership with Germany’s Bayer (BAYN: DE).

The advisory panel voted 10 to 0 with one abstention not to approve the supplemental New Drug Application (sNDA) for Xarelto, an oral anticoagulant, for the reduction of the risk of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) in combination with standard antiplatelet therapy. Janssen is seeking approval of rivaroxaban at a proposed dose of 2.5mg twice daily (BID) for a 90 day treatment duration.

Decision follows previous rejections