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Papers of the Week

Papers: 15 May 2021 - 21 May 2021

Human Studies, Pharmacology/Drug Development


2021 May 17


Dose selection for fremanezumab (AJOVY) phase 3 pediatric migraine studies using pharmacokinetic data from a pediatric phase 1 study and a population pharmacokinetic modeling and simulation approach.


Cohen-Barak O, Radivojevic A, Jones A, Fiedler-Kelly J, Gillespie M, Brennan M, Gutman D, Rasamoelisolo M, Hallak H, Loupe P, Kessler Y, Ning X, Levi M, Ahn AH, Rabinovich-Guilatt L
Cephalalgia. 2021 May 17:3331024211007789.
PMID: 34000848.


Potential fremanezumab doses for pediatric patients were evaluated using pharmacokinetic modeling and simulation. An open-label phase 1 pharmacokinetic and safety study was conducted in pediatric patients with migraine. This study's results together with refinement of the adult population pharmacokinetic model were used to determine fremanezumab dose recommendations for phase 3 pediatric studies.