European Commission Approves Aquipta for Acute Migraine Treatment in Adults

AbbVie Expands the Role of Aquipta in Migraine Care Across Europe

AbbVie has announced that the European Commission (EC) has approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura. The medicine can now be taken as needed during a migraine attack, giving patients another treatment option when symptoms occur.

This marks the second approved indication for Aquipta in the European Union. The oral CGRP receptor antagonist is already approved as a preventive treatment for adults with chronic or episodic migraine who experience four or more migraine days each month.

With this latest approval, Aquipta can now be used both to prevent migraine attacks and to treat them when they happen.

Why This Approval Matters

Migraine is much more than just a headache. It is a neurological disease that affects millions of people around the world and can have a major impact on daily life.

Many people living with migraine struggle with severe pain, sensitivity to light and sound, nausea, and difficulty concentrating. These symptoms can make it hard to work, spend time with family, or carry out normal daily activities.

The approval of Aquipta for acute treatment gives healthcare professionals another option to help patients manage migraine attacks quickly and effectively.

According to AbbVie, clinical data showed that Aquipta can provide both rapid and long-lasting relief, including sustained pain freedom for up to 48 hours after treatment.

Understanding the Burden of Migraine

Migraine affects around 14% of the global population and is more common in women than men. The condition is particularly common among people between the ages of 25 and 55 years.

For many patients, migraine attacks can occur frequently and unpredictably. Symptoms often include:

• Severe throbbing headache

• Nausea

• Sensitivity to light

• Sensitivity to sound

• Cognitive difficulties

• Reduced ability to perform daily activities

Beyond the physical symptoms, migraine creates a significant social and economic burden. Studies across Europe estimate that migraine contributes to productivity losses worth between €35 billion and €557 billion annually.

Because of its impact on work, family life, and overall quality of life, migraine remains one of the leading causes of disability worldwide.

Clinical Study Behind the Approval

The European Commission's decision was supported by data from the Phase 3 ECLIPSE clinical trial.

The study evaluated the efficacy, safety, and tolerability of Aquipta 60 mg compared with placebo for the treatment of acute migraine attacks in adults with a history of migraine, with or without aura.

The trial successfully met its primary endpoint by demonstrating that Aquipta was significantly more effective than placebo in helping patients achieve pain freedom two hours after treatment of their first migraine attack.

Researchers also observed positive results across several important secondary endpoints.

Patients treated with Aquipta experienced:

• Freedom from their most bothersome migraine symptom after two hours

• Improved pain relief at two hours

• Reduced need for rescue medication within 24 hours

• Sustained pain freedom from 2 to 48 hours after treatment

The study also showed that Aquipta delivered consistent benefits across multiple migraine attacks.

Details About the ECLIPSE Study

ECLIPSE was a large international Phase 3 clinical trial involving 1,328 adults between 18 and 75 years of age.

Participants had a history of migraine with or without aura and experienced between two and eight moderate-to-severe migraine attacks per month before entering the study.

The research was conducted across 149 clinical sites located in:

• Europe

• United Kingdom

• Japan

• China

• South Korea

• Taiwan

Participants treated four qualifying migraine attacks during the double-blind phase of the study and later entered an open-label extension period where all participants received Aquipta.

The study provided important evidence supporting the medicine's effectiveness for acute migraine treatment.

Safety and Tolerability Findings

During the placebo-controlled treatment period, Aquipta demonstrated a safety profile that was generally consistent with previous studies conducted for migraine prevention.

The most commonly reported side effects were:

• Nasopharyngitis

• Upper respiratory tract infection

Overall, the treatment was considered well tolerated.

What Is Aquipta?

Aquipta, also known as atogepant, is an oral calcitonin gene-related peptide (CGRP) receptor antagonist, commonly referred to as a gepant.

CGRP plays a major role in migraine development. By blocking CGRP receptors, Aquipta helps reduce migraine symptoms and prevent future attacks.

One of the key advantages of Aquipta is its flexibility.

For migraine prevention, it is taken once daily.

For acute migraine treatment, it can be taken only when needed during an attack.

This dual role makes Aquipta one of the few migraine therapies approved for both preventive and acute treatment.

Global Availability of Atogepant

Atogepant has already gained approval in more than 60 countries for migraine prevention.

The medicine is marketed under different brand names depending on the region:

• Aquipta in the European Union

• Qulipta in the United States

• Qulipta in Canada

• Qulipta in Israel

• Qulipta in Puerto Rico

With the latest European approval, patients and healthcare providers now have expanded access to this treatment across the migraine care pathway.

AbbVie's Commitment to Migraine Care

AbbVie continues to invest in migraine research and treatment development with the goal of improving the lives of people affected by this neurological condition.

The company focuses on advancing scientific understanding of migraine while supporting healthcare providers and patients through education, advocacy, and access to treatment options.

By expanding Aquipta's approved uses, AbbVie aims to help address unmet needs among people living with chronic and episodic migraine.

Looking Ahead

The European Commission's approval of Aquipta for acute migraine treatment represents an important step forward for migraine management in Europe.

Patients now have access to a single oral therapy that can be used both to prevent migraine attacks and to treat them when they occur. Clinical data from the Phase 3 ECLIPSE study demonstrated meaningful improvements in pain relief and symptom control, providing healthcare professionals with another valuable tool in migraine care.

As migraine continues to affect millions of people worldwide, new treatment options such as Aquipta have the potential to improve quality of life, reduce disability, and help patients regain control over their daily activities.