This article was originally published in Pharmaceutical Approvals Monthly
FDA staff that participated in the review of AstraZeneca’s anticoagulant.
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FDA’s review of AstraZeneca’s platelet inhibitor ticagrelor was tinged by the agency’s earlier evaluation and delayed approval of Lilly/Daiichi’s prasugrel for acute coronary syndromes.
The consistency of numerous analyses supporting a negative interaction between ticagrelor and high-dose aspirin, as used in the U.S., helped overcome FDA’s initial reluctance to approve AstraZeneca’s platelet inhibitor without a new trial.
The ticagrelor NDA ignited strong opinions from the cross-discipline team leader about sponsor AstraZeneca’s conduct, drawing a forceful response from the review division director.