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Kybella Approval Shows How To Work With FDA On Clinical Outcome Assessments

 
• By Sue Sutter

Kythera met FDA's strict evidentiary requirements for clinician- and patient-reported outcomes assessments through close and frequent interactions with the agency and by addressing regulatory concerns about the instruments' design, validation and use in Phase III trials for the submental fat treatment.

FDA's approval of Kythera Biopharmaceuticals Inc.'s chin fat treatment Kybella (deoxycholic acid) should serve as a case study for sponsors who wish to use clinical outcome assessments to support novel indications.

Over the course of several years, FDA staff worked with Kythera on the development and validation of clinician- and patient-reported...

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