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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.

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• By Neena Brizmohun

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New EU Approvals

 
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More from Product Reviews

Early Randomization Among Advice On How To Meet Both EMA & HTA Needs

 
• By Neena Brizmohun

Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.

Mysimba Passes EU Safety Probe, But Currax Must Explore Long-Term Heart Risks

 
• By Neena Brizmohun

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EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

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