MedPath
EMA Approval

Aquipta

N02CD07

atogepant

atogepant

Migraine Disorders

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.

Authorisations (3)

EMEA/H/C/005871

AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany

Authorised

August 11, 2023

EMEA/H/C/005871

AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany

Authorised

August 11, 2023

EMEA/H/C/005871

AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany

Authorised

August 11, 2023

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.

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