Basic Information
N02CD07
atogepant
Overview Summary
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.
Active Substances (2)
atogepant
atogepant
Documents (9)
Aquipta : EPAR - Procedural steps taken and scientific information after authorisation
June 28, 2024
CHANGES_SINCE_INITIAL_AUTHORISATION
Aquipta : EPAR - Risk Management Plan
August 25, 2023
RISK_MANAGEMENT_PLAN_SUMMARY
Aquipta : EPAR - Public Assessment Report
August 25, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of positive opinion for Aquipta
June 23, 2023
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Aquipta : EPAR - All authorised presentations
August 25, 2023
AUTHORISED_PRESENTATIONS
Aquipta : EPAR - Medicine Overview
August 25, 2023
OVERVIEW_DOCUMENT
Aquipta : EPAR - Product Information
August 25, 2023
DRUG_PRODUCT_INFORMATION
Aquipta : EPAR - Public Assessment Report
August 25, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Aquipta
June 23, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
Other information about Aquipta
Answer
Aquipta received a marketing authorisation valid throughout the EU on 11 August 2023.
Question
How is Aquipta used?
Answer
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.
Question
How does Aquipta work?
Answer
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.
Question
What benefits of Aquipta have been shown in studies?
Answer
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.
Question
What are the risks associated with Aquipta?
Answer
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.
Question
Why is Aquipta authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Aquipta?
Answer
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.