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

Authors: Cohenbarak O, Radivojevic A, Fiedler-Kelly J, Gillespie M, Brennan M, Gutman D, Rasamoelisolo M, Loupe P, Rabinovich-Guilatt L, Levi M
Conference: European Headache Federation (EHF)
Keywords: AJOVY, fremanezumab, migraine, Pediatric, pharmacokinetics
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Previous examination of the relationship between fremanezumab exposures and baseline body weight supports a weight cutoff of 45 kg of pediatric dose selection, with the approved adult dose of 225 mg monthly being appropriate or patients weighing >= 45 kg

As part of the pediatric phase 3 program for fremanezumab, the present analyses were conducted to determine the appropriate dose for migraine pediatric patients weighing <45 kg.

These analyses included a refinement of the adult fremanezumab population pharmacokinetic (PopPK) model using pediatric PK data from teh phse 1 study (TV48125-CNS-10141) in migraine patients 6 to 11 years old and simulation

European Headache Federation (EHF) conference; July 3-5 2020, Virtual.

By, Cohenbarak O, Radivojevic A, Aksana Jones, Jill Fiedler-Kelly, Gillespie M, Brennan M, Gutman D, Rasamoelisolo M, Loupe P, Rabinovich-Guilatt L, Levi M