PCN119 Patient-Reported Outcomes (PROs) in Antineoplastic Product Approvals in Europe and in the USA

 A total of 96 antidiabetic products were retrieved: 53 approved by the EMA (Table 1) and 43 by the FDA (Table 2). Generics were excluded.  Only two products with a PRO labeling claim were found in Europe (i.e., insulin glulisine and exenatide), and none in the USA. PROs identified in both claims were self-monitored blood glucose (SMBG) profiles and were used as secondary endpoints. See Tables 3 and 4.  Although insulin glulisine and exenatide were also approved by the FDA (on the same studies used in Europe) their US label did not mention any results based on SMBG profiles. Reasons for not including them in the label were not given in the corresponding medical reviews.  However, the analysis of other products’ reviews, such as insulin aspart or liraglutide (see Table 5), showed a reluctance from reviewers to include results based on SMBG profiles in the labels. Reviewers questioned the validity of the glucose profiles based on self-collected readings because of compliance issues and of a lower degree of accuracy of values obtained from glucometers vs. lab measures in a clinic.  Although measured in some cases, other PROs, such as quality of life or treatment satisfaction, were never considered for inclusion in labeling with any reasons given. This was consistent for both agencies. RESULTS Table 1. EMA Products Table 2. FDA Products