J&J Mulls Xarelto’s Next Steps After Another “Complete Response” In Acute Coronary Syndrome
This article was originally published in The Pink Sheet Daily
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.
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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.
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.
With positive data now in for Xarelto’s ability to treat and prevention recurrence of VTE, Janssen looks to file for a fourth indication for the novel anticoagulant, positioning the drug to crack a promising market that may be under-appreciated.