Patient-Reported Outcome Data Helps Dermira’s Hyperhidrosis Drug Qbrexza Win US FDA Nod
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.
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No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue
US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.
Getting With The PRO-gram: Making Patient-Reported Outcomes Work
When FDA’s guidance document on patient-reported outcomes was finalized five years ago, it was lauded as a milestone event for an industry interested in advancing patient-centered drug development. But implementation of the guidance hasn’t gone the way some had hoped – and actually may be dissuading sponsors from pursuing PRO labeling claims. Can FDA’s patient-centered drug development initiative help?
Incyte’s Jakafi Gets Additional Claim Based On Patient-Reported Outcomes
Jakafi is the first approved treatment for myelofibrosis, a rare bone marrow cancer, but Incyte will also be able to claim efficacy against the symptoms of the disease thanks to data in labeling from a patient-reported outcomes tool.