Vyepti
Vyepti (eptinezumab) was approved for the following therapeutic use:
Vyepti is indicated for the preventive treatment of migraine in adults.
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.
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.