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Ajovy
Published
Product name
Ajovy
Active ingredient
Fremanezumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ajovy (fremanezumab) was approved for the following therapeutic use:
Ajovy is indicated for the preventive treatment of migraine in adults.
How this medicine works
Fremanezumab is a fully humanised IgG2Δa/kappa monoclonal antibody produced by recombinant DNA technology that is derived from a murine precursor. Fremanezumab potently and selectively binds the calcitonin gene-related peptide (CGRP) ligand and blocks both CGRP isoforms (α-and β-CGRP) from binding to the CGRP receptor preventing the activation of the trigeminal system. While the precise mechanism of action by which fremanezumab prevents migraine attacks is unknown, it is believed that prevention of migraine is obtained by its effect modulating the trigeminal system. Fremanezumab is highly specific for CGRP and does not bind to closely related family members (for example, amylin, calcitonin, intermedin and adrenomedullin).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ajovy was considered favourable for the therapeutic use approved.
Sponsor