Takeda Rozerem Clinical Significance Debated In FDA Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
The "curious" failure of subjective secondary endpoints to agree with the efficacy of Takeda’s Rozerem on objective sleep measures contributed to a debate at FDA over the clinical significance of the insomnia therapy.
You may also be interested in...
FDA, Merck Clash Over Value Of Subjective Insomnia Endpoints
Merck favors the subjective study endpoints, perhaps with an eye toward potential marketing challenges, and the Rozerem experience could haunt Merck’s dreams.
FDA Priority Review Status Refusals Show Need For Clinical Outcomes Data
Sponsors who plan to seek priority review status need to show a superior effect on clinical outcomes, an examination of priority review requests rejected by FDA suggests
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