Pfizer/BI Spiriva QT Concern Based Primarily On Outliers In Exercise Study
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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
You may also be interested in...
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
September 2010 Approvals
Product
Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class