MAIDENHEAD, UK, 10 June 2026 — AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA^® (atogepant), an oral tablet, as an option for the acute treatment of migraine with or without aura in adults, only if, for previous migraines: at least 2 triptans were tried and they did not work well enough, or triptans were contraindicated or not tolerated, and nonsteroidal anti-inflammatory drugs (NSAIDs) and paracetamol were tried but did not work well enough.¹

Migraine is a long‑term health condition affecting around 10 million adults in the UK, yet it remains widely misunderstood as merely a headache.^3,4 Characterised by a range of symptoms — including recurrent moderate-to-severe throbbing or pulsating head pain, nausea, vomiting and sensitivity to light and sound — migraine can disrupt daily life and prevent people from carrying out their daily activities.^4,5 Despite its prevalence and severity, many people report that their condition is dismissed or stigmatised; in a survey by the Migraine Trust in 2024, 89% of 2,028 people surveyed living with migraine reported that migraine had affected their mental health.⁶

Beyond the impact on individuals, migraine also has a significant impact on productivity in the UK, driving high levels of absenteeism and reduced performance at work. Its unpredictable and debilitating symptoms place real pressure on employees and employers, costing the UK economy approximately £8.8 billion each year in lost productivity due to absenteeism and presenteeism.^7,8

Rob Music, CEO at the Migraine Trust, said: "Access to appropriate care for people with migraine can be seriously inconsistent, creating a postcode lottery. Many people with migraine tell us they have struggled to access treatments or had to wait a long time before they could see a specialist. This is concerning because those living with migraine typically try a number of medicines before finding what works best for them. That is why it is so important that there are a variety of treatments available and clinicians have clear guidance on how they should be prescribed. We therefore welcome today's update from NICE, which adds an additional treatment option for eligible migraine patients."

“The NICE recommendation means an additional treatment option for suitable individuals experiencing acute migraine attacks,” said Professor Alex Sinclair, Professor of Neurology at the University of Birmingham and Chair of The British Association for the Study of Headache (BASH) Council. “This treatment option will allow clinicians to consider a wider range of approaches when managing acute migraine.”

The recommendation is supported by data from ECLIPSE, the pivotal Phase 3 clinical study evaluating the safety, efficacy and tolerability of atogepant for the acute treatment of migraine.³ The study included adults with migraine with or without aura and a history of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to screening or first visit. The acute study met its primary endpoint of percentage of patients achieving pain freedom at 2 hours post‑dose (first attack), with 24.3% of atogepant patients vs 13.1% of placebo patients achieving pain freedom at 2 hours (p<0.0001)³

There were no individual treatment emergent adverse events (TEAEs) with an incidence ≥ 2% for the first attack in the double-blind period. The most frequent TEAEs (≥ 2%) during the double-blind period were nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%).³

Rachael Millward, Medical Director, AbbVie UK, said: “Migraine is a complex neurological condition that can have a profound impact on quality of life, leading to social withdrawal and missed work. AbbVie remains committed to addressing the ongoing challenges faced by people living with this condition. This NICE recommendation will enable eligible patients in England and Wales access to an acute treatment option for the treatment of their migraine attacks”

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NOTES TO EDITORS

About migraine

Migraine is a severe and painful long-term health condition.⁹ Migraine is highly prevalent, ranking as the second leading cause of disability globally,¹⁰ with an estimated 10 million people living with the condition in the UK.⁵

Migraines attacks can involve a range of symptoms which affect the whole body, including a throbbing headache, nausea, fatigue, vomiting and increased sensitivity to light and sounds.¹¹ People living with migraine may experience migraine, both with aura and without aura, at different times.¹³ Migraine without aura is the most common form and is characterised by the absence of aura symptoms during an attack.¹³ An aura refers to a set of neurological symptoms that can occur as part of a migraine attack and may include visual, speech and sensory disturbances.⁵

Migraine can affect people’s ability to work, socialise and care for dependents, as well as having an impact on mental health.¹² Evidence shows that the incidence of anxiety is approximately four times higher among those living with migraine.¹³ Despite its prevalence and burden, migraine is often underdiagnosed and not optimally treated.¹⁴ Based on data from NHS England (2018), supported by The Migraine Trust, approximately 16,500 emergency admissions for headaches and migraine attacks could be avoided with the right care pathways, yet hospital admissions continue to rise.¹⁵

About AQUIPTA^® (atogepant)

Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist licensed for the acute treatment of migraine with or without aura in adults¹, and for the prophylaxis of migraine in adults who have at least four migraine days per month.² Atogepant blocks the binding of CGRP to the receptor and antagonises CGRP receptor function.^2,16,17 CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology.^{2, 16} Studies have shown that CGRP levels are elevated during migraine attacks, and selective CGRP receptor antagonists offer clinical benefits in migraine. ^17-19

About the atogepant Phase 3 ECLIPSE study^3,10

Atogepant was evaluated for the acute treatment of migraine in ECLIPSE, a pivotal Phase 3 study, evaluating the safety, efficacy and tolerability of atogepant for the acute treatment of migraine.

ECLIPSE was a multicentre, randomised, double-blind, multiple attack, placebo-controlled study. The study included adults with migraine, with or without aura, who had experienced two to eight migraine attacks of moderate-to-severe headache pain in the three months prior to screening or first visit.

Participants were randomised 3:1:1:1 to one of four treatment sequences, in which they received the study treatment (one dose of placebo and three doses of atogepant 60mg administered in different orders per treatment sequence) to treat four qualifying migraine attacks on an outpatient basis. Following treatment of the four qualifying attacks, participants entered an open-label treatment period for a minimum of eight weeks, up to Week 24. The primary endpoint was the percentage of participants achieving pain freedom at 2 hours post-dose (first attack). Ranked secondary endpoints included percentage of participants who, at 2 hours post-dose (first attack), were free of their most bothersome symptom (MBS). MBS was pre-defined at baseline: photophobia (44%; sensitivity to light), phonophobia (25%; sensitivity to sound) and nausea (31%) as their most bothersome symptom at baseline. An additional ranked secondary endpoint included the percentage of participants who experienced pain relief at 2 hours (pain relief was defined as a reduction in pain from moderate-severe to mild-no headache).

Primary endpoint

24.3% (n=146/602) atogepant patients achieved pain freedom at 2 hours post-dose (attack 1) vs 13.1% (n=80/612) with placebo, p<0.0001

Secondary endpoints

Statistically significant improvements over placebo (p≤0.0001) were also observed across 12 of the 16 ranked secondary endpoints, including sustained pain relief at 2–24 and 2–48 hours post-dose.³

57.8% (n=348/602) atogepant patients achieved sustained relief at 2–24 post-dose (attack 1) vs 26.8% (n=164/612) with placebo

51.7% (n=311/602) atogepant patients achieved sustained relief 2–48 hours post-dose (attack 1) vs 23.2% (n=142/612) with placebo

Safety profile

Participants receiving atogepant and placebo had similar safety profiles following the first attack. At both 48 hours and 30 days post-dose for the first attack in the double-blind period, atogepant was associated with slightly higher rates of adverse events related to study treatment compared with placebo, but none were severe or serious, and only one led to treatment discontinuation.

Across all attacks during the double-blind period, the most frequent TEAEs (≥ 2%) were nasopharyngitis (4.6%) and upper respiratory tract infection (2.3%).

For full information on the adverse reactions of atogepant, please refer to the Summary of Product Characteristics.

About AbbVie in neuroscience

At AbbVie, our commitment to preserving the personhood of people around the world living with neurological and psychiatric disorders is unwavering. With more than three decades of experience in neuroscience, we are providing meaningful treatment options today and advancing innovation for the future. AbbVie's neuroscience portfolio consists of approved treatments in neurological conditions, including migraine, movement disorders and psychiatric disorders, along with a robust pipeline of transformative therapies. We have made a strong investment in research and are committed to building a deeper understanding of neurological and psychiatric disorders. Every challenge makes us more determined and drives us to discover and deliver advancements for those impacted by these conditions, their care partners and clinicians.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas — immunology, neuroscience and oncology — and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at abbvie.co.uk. Follow AbbVie | UK on LinkedIn and YouTube (@abbvie-uk).