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Patient-Reported Outcome Data Helps Dermira’s Hyperhidrosis Drug Qbrexza Win US FDA Nod

 
• By Sue Sutter

Co-primary endpoint was Axillary Sweating Daily Diary, a novel PRO instrument developed by Dermira with FDA input, assessed sweating severity and impact of sweating on a person’s daily activities; results complemented quantitative measure of sweat production in Phase III trials.

Sweaty spot on the shirt because of the heat, worries and diffidence

Dermira Inc.’s Qbrexza (glycopyrronium) gained US FDA approval for primary axillary hyperhidrosis (excessive underarm sweating) on the strength of a novel patient-reported outcome measure that served as a co-primary endpoint in two pivotal trials.

The Axillary Sweating Daily Diary (ASDD), a questionnaire developed by Dermira, assessed sweating severity and the impact of sweating on...

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More from Approvals

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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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• By Neena Brizmohun

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