FDA releases guidance on colitis endpoints

In draft guidance released Friday, FDA said ideal efficacy endpoints for studies of ulcerative colitis (UC) therapies should include both a patient-reported assessment of signs and symptoms and a physician-reported endoscopic and histological assessment.

FDA also recommended a clinical remission primary endpoint that incorporates "well-defined" patient-assessed outcomes such as stool frequency and rectal bleeding, as well as endoscopy scores. It said sponsors should discuss endpoints evaluating mucosal healing with FDA before conducting a study because existing scoring systems do not yet provide sufficient histological criteria to assess mucosal healing. ...