Scaling Approaches for Pediatric Dose Selection: The Fremanezumab (AJOVY®) Journey to Select a Phase 3 Dose Using Pharmacokinetic Data from a Phase 1 Study

Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and prevents it from binding to the CGRP receptor. The safety, tolerability, pharmacokinetics (PK), and efficacy of fremanezumab for treating migraines administered as a o...

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Bibliographic Details
Published in:Pharmaceutics 2021-05, Vol.13 (6), p.785
Main Authors: Jones, Aksana, Cohen-Barak, Orit, Radivojevic, Andrijana, Fiedler-Kelly, Jill
Format: Article
Language:English
Subjects:
Adults
Age
Antibodies
Bioavailability
Estimates
fremanezumab
Migraine
Patients
pediatric dose selection
pediatric migraine
Pediatrics
Pharmacokinetics
pharmacometrics
Population
Revisions
Simulation
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Summary:Fremanezumab, a fully humanized IgG2Δa/kappa monoclonal antibody, selectively targets the calcitonin-gene-related peptide (CGRP) and prevents it from binding to the CGRP receptor. The safety, tolerability, pharmacokinetics (PK), and efficacy of fremanezumab for treating migraines administered as a once monthly 225 mg dose or a once quarterly 675 mg dose have been well characterized in adults. The fremanezumab exposure and body weight relationship supported the use of the approved 225 mg monthly adult dose for pediatric patients weighing ≥45 kg. In the pediatric Phase 3 program, a 120 mg dose for patients weighing
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics13060785