Presentation (CTI)

OBJECTIVES: The World Health Organization identifies obesity as a global public health crisis. Since 1990, adult obesity has more than doubled worldwide and adolescent obesity has quadrupled. Obesity is associated with an increased risk of diabetes, cancer, and cardiovascular disease as well as substantial economic burden. Considering the growing interest in establishing effective obesity treatments and interventions, this study compared COAs and concepts in FDA and EMA obesity-related drug labels, assessed alignment with current regulatory guidance on obesity drug development, and explored whether digital health technologies (DHTs) could address gaps between guidance recommendations and labeled evidence.
METHODS: PROINSIGHT (COA guidelines) and PROLABELS (drug labels with COA claims) were searched for ‘obesity’, ‘obesity management’, and ‘overweight’. Identified COAs and concepts of interest were evaluated. Atlas (a DHT library) was then reviewed to assess whether DHTs could measure concepts identified in guidance but absent from labels.
RESULTS: Two COAs were identified in PROINSIGHT (PHQ-9 and C-SSRS), both FDA-recommended patient-reported outcomes (PROs) for neuropsychiatric symptoms. Neither these PROs nor the concept neuropsychiatric symptoms appeared in the eight labels. Most COAs in labels assessed quality of life (FDA 4; EMA 1 COAs) followed by physical function (FDA 0; EMA 3 COAs). PROs predominated across FDA and EMA labels, although one EMA label included a performance outcome (6-Minute Walk Test). Several recommended concepts, including sleep parameters, were absent from labels. Atlas identified multiple DHTs which passively measure sleep, and overweight/obesity had the second-largest evidence base for DHT sleep assessment.
CONCLUSIONS: Obesity labels do not fully reflect concepts emphasized in FDA and EMA guidance, indicating a gap between regulatory measurement ambition and labeled evidence. DHTs may help bridge this gap through passive, lower-burden assessment of underrepresented outcomes, including sleep. As guidance evolves, digital endpoints may support evidence generation relevant to regulators and payers in future obesity drug development and evaluation.