Recapturing Missing Vital Status Not Enough To Rescue Xarelto ACS Claim
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.
You may also be interested in...
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.
Some members of FDA’s Cardiovascular and Renal Drugs Advisory Committee questioned whether the high rate of study dropouts and consent withdrawals in rivaroxaban’s pivotal trial for acute coronary syndromes resulted from elements of the trial’s design, including patient consent and follow-up procedures and the primary analysis.