Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?

ABSTRACT: Mobility is defined as the ability to independently move around the environment and is a key contributor to quality of life, especially in older age. The aim of this study was to evaluate the use of mobility as a decisive outcome for the marketing authorisation of drugs by the European Medicines Agency (EMA). Fifteen therapeutic areas which commonly lead to relevant mobility impairments and alter the quantity and/or the quality of walking were selected: two systemic neurological diseases, four conditions primarily affecting exercise capacity, seven musculoskeletal diseases and two conditions representing sensory impairments. European Public Assessment Reports (EPARs) published by the EMA until September 2020 were examined for mobility endpoints included in their 'main studies'. Clinical st

SUBMITTER: Jaeger SU 

PROVIDER: S-EPMC8789320 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature