Evaluation of marketing authorization and clinical implementation of ulipristal acetate for uterine fibroids.

ABSTRACT: Ulipristal acetate (UPA) is a medical treatment for uterine fibroids and was authorized for surgical pre-treatment in 2012 after the conduct of the PEARL I and II randomized controlled trials and for intermittent treatment after the observational PEARL III and IV trials. However, UPA came into disrepute due to its temporary suspension in 2017 and 2020 because of an apparent association with liver injury. This clinical opinion paper aims to review the process of marketing authorization and implementation of UPA, in order to provide all involved stakeholders with recommendations for the introduction of future drugs. Before marketing authorization, the European Medicines Agency (EMA) states that Phase III registration trials should evaluate relevant outcomes in a representative population, wh

SUBMITTER: Middelkoop MA 

PROVIDER: S-EPMC9071218 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature