ATLAS Data Not Strong Enough To Support Xarelto’s Use In ACS, FDA Panel Says
Six of 11 members of the Cardiovascular and Renal Drugs Advisory Committee voted against rivaroxaban’s approval for acute coronary syndromes, saying concerns about missing data in the pivotal trial raised doubts about the efficacy results and could not support creating a new standard of care by adding the Factor Xa inhibitor to dual-antiplatelet therapy.
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FDA’s third rejection of J&J’s attempt to expand use of Xarelto to ACS patients comes as competing oral anticoagulants await agency action on pending applications that could match Xarelto’s breadth of approved indications.
FDA rejection was expected following a negative advisory committee meeting in January, when panelists concluded that a new trial would be needed to expand use to ACS.
Janssen made “heroic” efforts to track down vital status for subjects who withdrew from the ATLAS acute coronary syndromes trial, but the data added little to the interpretation of the primary composite endpoint and had a slightly negative effect on all-cause mortality results, FDA advisory committee members said.