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
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