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Vyepti
Published
Product name
Vyepti
Active ingredient
Eptinezumab
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vyepti (eptinezumab) was approved for the following therapeutic use:
Vyepti is indicated for the preventive treatment of migraine in adults.
How this medicine works
Eptinezumab is a humanised immunoglobulin G1 (IgG1) antibody that binds to α- and β- forms of human calcitonin gene-related peptide (CGRP) ligand with low picomolar affinity preventing its activation of the CGRP receptors. Elevated blood concentrations of CGRP have been associated with migraine.Eptinezumab is highly selective and does not bind to any of the related neuropeptides amylin, calcitonin, adrenomedullin and intermedin.
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 Vyepti was considered favourable for the therapeutic use approved.
Sponsor