Toprol-XL Eyed As Precedent For Brilinta Labeling On U.S. Efficacy Data
Executive Summary
Labeling for AstraZeneca's antiplatelet agent Brilinta could follow in the mold of the company's own beta-blocker Toprol-XL in reflecting dissimilar efficacy reported for U.S. patients compared with those in the rest of the world
You may also be interested in...
Multiple Aspirin Dose Analyses Reassured FDA On Brilinta’s U.S. Efficacy
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.
Brilinta "Complete Response" Letter Suggests FDA Unswayed On U.S. Efficacy
Agency asks AstraZeneca for additional analyses of data from the 18,000-patient PLATO study, in which no benefit of ticagrelor over clopidogrel was seen in U.S. acute coronary syndrome patients.
In Multinational Trials, U.S. Often Lags In Efficacy, FDA Analysis Finds
As drug developers continue to move clinical trials overseas, FDA is keeping a close eye on the differential results that sometimes arise between U.S. and foreign subject populations, potentially affecting the usability of hard-won data for drug applications.