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Aquipta
Australian Prescription Medicine Decision Summary
Published
Product name
Aquipta
Active ingredient
Atogepant
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Aquipta (atogepant) was approved for the following therapeutic use:
Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
How this medicine works
Atogepant is an orally administered, small molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to the receptor and antagonises CGRP receptor function. CGRP is a neuropeptide that has been associated with migraine pathophysiology. In the trigeminovascular system, CGRP modulates nociceptive signalling and inflammation, and also functions as a vasodilator.
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 Aquipta was considered favourable for the therapeutic use approved.
Sponsor