Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence.

ABSTRACT:

Objectives

To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.

Design

Cross-sectional.

Setting

European Medicines Association (EMA), US Food and Drug Administration (FDA), Health Canada and Australian Therapeutic Goods Administration (TGA).

Participants

Apixaban, dabigatran, edoxaban and rivaroxaban marketing authorisations.

Outcome measures

Concordance among regulatory agencies with respect to (1) premarket evidence used to establish efficacy and safety and (2) postmarket safety boxed warnings and postmarketing study requirements.

Results

Apixaban, dabigatran and rivaroxaban were approved by each

SUBMITTER: Mooghali M 

PROVIDER: S-EPMC11529451 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature