Aquipta
Authorised
This medicine is authorised for use in the European Union
atogepant
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Aquipta is a medicine used to prevent migraines in adults who have migraines at least 4 days a month.
Aquipta contains the active substance atogepant.
Aquipta is available as tablets to be taken by mouth once a day. It can only be obtained with a prescription.
For more information about using Aquipta, see the package leaflet or contact your doctor or pharmacist.
The exact way that Aquipta works is not fully understood. The active substance in Aquipta, atogepant, attaches to receptors (targets) for proteins called CGRP and amylin-1. These proteins are involved in the development of migraine. By attaching to these receptors, the medicine prevents CGRP and amylin-1 from binding to them. This helps prevent migraines from occurring.
Aquipta was shown to reduce the number of days patients have migraines in two main studies.
In one study involving 882 patients who experienced at least 4 migraines a month, treatment with Aquipta for 12 weeks reduced migraines from around 8 days a month to around 3 to 4 days a month, compared with around 5 days for patients taking placebo (a dummy treatment).
In another study involving 760 patients who experienced at least 15 headache days a month with 8 out of these being migraine days, treatment with Aquipta for 12 weeks reduced migraines from around 19 days a month to around 12 days a month, compared with 14 days for patients taking placebo.
For the full list of side effects and restrictions with Aquipta, see the package leaflet.
The most common side effects with Aquipta (which may affect up to 1 in 10 people) include nausea (feeling sick), constipation, tiredness, somnolence (sleepiness), decreased appetite and decreased weight.
Aquipta can reduce the number of days patients have migraines. Most of the side effects are mild or moderate in severity. Following concerns about a possible link to liver injury, an in-depth safety analysis provided reassurance about the medicine’s liver safety profile. The European Medicines Agency therefore decided that Aquipta’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aquipta have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Aquipta are continuously monitored. Suspected side effects reported with Aquipta are carefully evaluated and any necessary action taken to protect patients.
Aquipta received a marketing authorisation valid throughout the EU on 11 August 2023.
Product information
Latest procedure affecting product information:
II/0005
14/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Aquipta
- Active substance
- atogepant
- International non-proprietary name (INN) or common name
- atogepant
- Therapeutic area (MeSH)
- Migraine Disorders
- Anatomical therapeutic chemical (ATC) code
- N02CD07
Therapeutic indication
Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month
News on Aquipta
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