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Patient-Reported Outcomes Data Earned Kybella A Claim For Emotional Impacts

 
• By Sue Sutter

Labeling for the submental fat treatment includes a sentence about improvements in overall patient-reported satisfaction and self-perceived visual attributes based on questionnaire results from the Phase III trials.

FDA concluded results from a patient-reported outcomes measure could support a labeling claim for Kythera Biopharmaceuticals Inc.'s Kybella (deoxycholic acid) despite initial doubts about the instrument's ability to measure the emotional impacts of submental fat.

The Patient-Reported Submental Fat Impact Scale (PR-SMFIS) is a six-item questionnaire designed to evaluate the visual and emotional impacts of...

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