OBJECTIVES: Acromegaly is a rare acquired disorder resulting from the excessive production of growth hormone by the anterior pituitary gland, and often diagnosed in middle-aged adults. It is characterized by progressive somatic disfigurement (e.g., broadened extremities, thickened soft tissue, and widened face) and systemic manifestations. The objectives of this study were 1) to identify patient-reported outcome (PRO) claims in products approved for the treatment of acromegaly by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and 2) to identify the endpoint positioning of the PROs when measured. METHODS: The EMA and FDA websites were explored to identify all products approved for acromegaly. PROLabels was used to identify products with a PRO claim in label. All corresponding clinical reviews (FDA), and assessments reports (EMA) were reviewed to check for endpoint positioning. RESULTS: Six products were approved (from 1978 to 2014) with the indication of acromegaly (representing five INN, i.e., pegvisomant, octreotide acetate, lanreotide, bromocriptine mesylate, and pasireotide). FDA has approved all products, and EMA only two of them (i.e., pegvisomant and pasireotide). For the products approved by both agencies, the same data were submitted. PRO claims were found in the label of pegvisomant (EMA/FDA), octreotide acetate (FDA) and pasireotide (EMA/FDA). For pegvisomant, claims were symptoms-related, with FDA providing much more detailed information in the label than the EMA. Claims were also symptoms-related for octreotide acetate. As for pasireotide, discrepancies were found between agencies. An HRQL claim was found in the European label (improvements measured by the AcroQoL), but not in the FDA label, while symptom claims were retrieved in the FDA label, but not in the EMA’s. For all products, PROs were considered secondary endpoints. CONCLUSIONS: The perspective of the patients with acromegaly is recognized by the FDA and the EMA, with still some discrepancies between agencies.