FDA again rejects label expansions for J&J's Xarelto

FDA issued complete response letters for a pair of sNDAs from Johnson & Johnson (NYSE:JNJ) seeking approval of Xarelto rivaroxaban to reduce the risk of thrombotic cardiovascular events and risk of stent thrombosis in combination with antiplatelet therapy in patients with acute coronary syndrome (ACS). J&J could not be reached for details on the contents of the letters. FDA has twice before rejected an sNDA for Xarelto to reduce risk of thrombotic cardiovascular events and once rejected an sNDA for Xarelto to reduce the risk of stent thrombosis.

FDA's previous rejections for Xarelto to reduce risk of thrombotic cardiovascular events were because of inadequate data from the Phase III ATLAS ACS 2 TIMI trial, on which the applications have been based. The pharma has previously sought approval of continued use of the drug using data from the trial, but this time was seeking to expand Xarelto's label to include the drug's use for 90 days based on new analyses of data from the trial. Last month, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 10-0, with one abstention, against approval after reviewers noted that ATLAS ACS 2 was not designed to evaluate the use of Xarelto with a limited duration. The committee did not discuss the stent thrombosis indication (see BioCentury Extra, Jan. 16). ...