The third time wasn’t the charm. The FDA these days turned turned down– for the third time– the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson Johnson & Johnson) for use in acute coronary syndrome individuals to lessen MI, stroke or death. In addition, the FDA– for the second time– turned down the sNDA for rivaroxaban in the same population for the reduction of stent thrombosis.
The complete response letters come as minor shock, considering that an FDA advisory panel final month strongly recommended against approval for the indications. As I’ve reported right here on several occasions, the huge sum of missing data from the pivotal ATLAS ACS 2-TIMI 51 trial has been the source of the company’s inability to acquire the ACS indications. Though J&J has produced significant efforts to fill in the missing data, the FDA reviewers and panel members did not think the information was reliable sufficient to attain firm conclusions about the relative safety and efficacy of rivaroxaban for use in ACS.
“We remain committed to delivering sufferers who have suffered from acute coronary syndrome with additional safety towards stent thrombosis and secondary lifestyle-threatening cardiovascular occasions,” mentioned a J&J executive in a statement. “We are evaluating the contents of the letters and will establish the acceptable up coming actions.”
FDA Rescinds Xarelto REMS
In a separate improvement, the FDA has rescinded the Xarelto REMS (Risk Evalaution and Mitigation Technique). The company had been required to communicate the risks of an increased threat of thrombotic events when the drug was discontinued without having an ample alternative anticoagulant and of decreased efficacy when not taken with the evening meal.
FDA Once Yet again Rejects New Indication For Johnson & Johnson"s Xarelto
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