Pfizer/BI Spiriva QT Concern Based Primarily On Outliers In Exercise Study
This article was originally published in Pharmaceutical Approvals Monthly
Spiriva QT concerns stemmed from outliers in exercise study, review documents suggest. FDA requested data and analyses from sponsor but were unable to determine tiotropium’s potential for QT prolongation. Boehringer arguments include lack of class effect with anticholinergics. FDA ultimately included outlier data in labeling and requested a thorough Phase IV QT study
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