Public Summary SwissPAR – Aquipta®

Public Summary SwissPAR dated 24.07.2024

Aquipta® (active substance: atogepant)

Authorisation in Switzerland: 6 March 2024

Medicinal product (tablets) for prophylactic treatment of migraine in adults

Information on authorisation

The medicinal product Aquipta contains the active substance atogepant and is taken in the form of tablets.

Aquipta is used to treat migraine in adults for whom preventive treatment is indicated. The doctor with experience in the area of migraine treatment will support the patient as regards further treatment.

Migraine is a common condition that affects around 10–15% of the adult population in western countries. Migraine is characterised by regular, often severe headaches, which may be accompanied by sensory (aura) and other symptoms such as nausea, vomiting and sensitivity to light.

The exact mechanism of action of atogepant is not yet fully understood. Atogepant, the active substance in the medicinal product Aquipta, blocks specific proteins, known as CGRP[1], from binding to receptors[2]. These proteins are involved in the development of migraine. The medicinal product Aquipta therefore helps to prevent the occurrence of migraine.

In deciding whether to authorise the medicinal product Aquipta, Swissmedic took into account the assessments of the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the corresponding medicinal product information texts.

Since the assessment of the clinical data was based on the assessment reports of these foreign authorities, the preconditions for a full SwissPAR (Swiss Public Assessment Report – a detailed report for professionals) and a resulting Public Summary SwissPAR are not met. Swissmedic refers to the authorisations by the foreign reference authorities.

[1] CGRP: Calcitonin gene-related peptide

[2] Receptor: A receptor is a protein or a protein complex located on the surface of, or inside, cells. When a specific substance binds to a receptor, a reaction is triggered in the cell.

Further information on the medicinal product

Information for healthcare professionals:

Information for patients (package leaflet): 

Healthcare professionals can answer any further questions.

 

The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Public Summary SwissPAR.

Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals.

New findings that could impair the quality, efficacy or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.