Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine.

ABSTRACT:

Aims

Fremanezumab is a fully humanized IgG₂ Δa/κ monoclonal antibody specific for calcitonin gene-related peptide developed and approved for the preventive treatment of migraine in adults. The population pharmacokinetics (PK) of fremanezumab were characterized in healthy subjects and patients with chronic migraine and episodic migraine, including the effects of intrinsic and extrinsic factors on PK variability.

Methods

Nonlinear mixed effects modelling was performed using NONMEM with data from 7 phase 1-3 clinical trials evaluating selected intravenous and subcutaneous dose regimens. The influence of covariates on fremanezumab PK was assessed and model evaluation was performed through visual predictive checks.

Results

A 2-compartment model with first-order

SUBMITTER: Fiedler-Kelly JB 

PROVIDER: S-EPMC6955415 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature