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  • AbbVie’s AQUIPTA[®]▼(atogepant) Is Recommended By NICE For The Prevention Of Migraine In Adults
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AbbVie’s AQUIPTA[®]▼(atogepant) Is Recommended By NICE For The Prevention Of Migraine In Adults

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PRESS RELEASE - For UK consumer, medical and trade media only

  • The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA® (atogepant), the oral, once-daily calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) as an option in suitable patients for preventing migraine in adults who have at least 4 migraine days per month, only if at least 3 preventative treatments have not worked.1 Suitable patients will soon have the option to be prescribed atogepant on the NHS in England and Wales.
  • The NICE recommendation follows the Scottish Medicines Consortium who accepted atogepant for restricted use in suitable patients with chronic and episodic migraine who have had prior failure on 3 or more migraine preventive treatments on 9th October 2023.2 This means that atogepant is now available on the NHS.
  • The recommendation is based on results from three pivotal Phase 3 studies in which the treatment demonstrated significant reduction in mean monthly migraine days from baseline across 12 weeks.3-8

MAIDENHEAD, UK, 11 APRIL 2024 — AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA® (atogepant), as an option for preventing migraine in adults who have at least 4 migraine days per month, only if at least 3 preventive treatments have not worked.1 The NICE recommendation follows the Scottish Medicines Consortium who accepted atogepant for restricted use in patients with chronic and episodic migraine who have had prior failure on 3 or more migraine preventive treatments, on 9th October 2023.2

Migraine is a severe and painful long-term health condition.9 In 2023, it was estimated around 10 million adults in the UK have experienced, or live with migraine,10 with around 1 in 5 women and 1 in 12 men being affected.11 Migraine can have an impact on the health and wellbeing of patients,12 which can affect their ability to work, socialise and care for dependents, along with having an impact on mental health.13 Despite the prevalence and impact of migraine, people report their experience is often dismissed or trivialised in wider society.12 This has contributed to the sense of burden and invisibility that many feel when accessing care.12 In 2021/22, over 33,000 hospital admissions for migraine were seen in England – an increase of 21% from the previous year, with waiting times for specialist care nearly doubling in parts of the UK over the past 2 years.10

“A migraine attack can be incredibly debilitating. Symptoms can include intense head pain, loss of or changes to senses and lack of ability to carry out day to day life,” commented Rob Music, Chief Executive of the Migraine Trust, adding: “It is positive to see even more therapies emerging for people with migraine after many still rely on treatments developed for other conditions. We now need to ensure access to the newer treatments is swift, so that migraine patients can benefit from them.”

“We know that people living with migraine may battle for years without an effective treatment to mitigate the daily struggles of living with this debilitating condition,” said Professor Peter Goadsby, Honorary Consultant Neurologist, King’s College Hospital, adding: “The decision by NICE should have a positive impact on patients who are eligible to receive atogepant as the treatment has been shown to reduce significantly the number of mean monthly migraine days in pivotal trials. This welcome news increases the treatment options available that clinicians can offer to suitable patients, providing them with access to an additional preventive treatment that is now available on the NHS in England and Wales.”

The recommendation is supported by data from three pivotal Phase 3 clinical studies evaluating atogepant 60 mg once-daily in adults living with episodic (ADVANCE and ELEVATE) and chronic (PROGRESS) migraine.3-45678 In the ADVANCE, ELEVATE and PROGRESS trials, the treatment met the primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks vs. placebo. Additionally, the treatments achieved significant reductions from baseline in several secondary efficacy endpoints compared to placebo: mean monthly headache days and mean monthly acute medication days,3,6-78 along with an additional achievement of ≥50% reduction in 3-month average of monthly migraine days in the ELEVATE study.8 Atogepant was generally well tolerated, with the most commonly reported adverse reactions in the ADVANCE and PROGRESS trials being nausea (7%), constipation (7%) and fatigue/somnolence (5%).3 The majority of adverse events were mild, and none were serious.3 In the ELEVATE study, treatment-emergent adverse events were reported by 81 participants (52%) in the atogepant group (n=156). The most common (≥5%) treatment-emergent adverse events were constipation (10%), COVID-19 (8%), nausea (7%), and nasopharyngitis (5%).8 Most treatment-emergent adverse events were considered by the investigator to be mild or moderate in severity.8 The Phase 3 ELEVATE study has recently been published in the Lancet Neurology.8

Rachael Millward, Medical Director, AbbVie UK said: “Migraine is a complex neurological condition with attacks that are often incapacitating and can include headache pain, nausea, sensitivity to light and sound. AbbVie has an extensive history in migraine research and is committed to addressing the unmet needs of people living with this debilitating condition. The recommendation from NICE means that suitable people living with migraine in England and Wales will have access to an additional treatment option that has the potential to improve their quality of life.”

-Ends-

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/ or via the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card app, available in the Google Play or Apple App Stores. Adverse events should also be reported to AbbVie at GBPV@abbvie.com. By reporting side effects, you can help provide more information on the safety of this medicine.

UK media contacts:

Sophia James                                                             Anastasios Koutsos

AbbVie UK                                                                  Health Unlimited

T: +44 (0)7977 055 997                                              T: +44 20 7751 5083

E: sophia.e.james@abbvie.com                                 E: anastasios.koutsos@unlimitedgroup.com

NOTES TO EDITORS:

About Migraine

Migraine is a severe and painful long-term health condition.9 Migraine attacks can involve the whole body, with sensitivity to light, sounds and smells, nausea, and fatigue.9 It is highly prevalent, standing as the second highest cause of disability globally,14 with an estimated 10 million people living with migraine in the UK.10

Migraine can be episodic or chronic. People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine for three or more months.3,15 It is differentiated from episodic migraine, which is characterised by 4–14 headache days per month,3,15 greater prevalence of comorbid conditions, as well as higher frequency of headache and migraine days.15

Migraine can affect people’s ability to work, socialise and care for dependents, along with having an impact on mental health.13 Findings show that incidence of anxiety is approximately four times higher in those living with migraine.10 Despite its prevalence and impact, migraine is often under diagnosed and not optimally treated.16 It is suggested in a 2023 Migraine Trust report that as many as 16,500 emergency admissions for headaches and migraine attacks could be avoided with the right care pathways, yet hospital admissions are on the rise.10

About AQUIPTA® (atogepant)

Atogepant is a once-daily, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the prophylaxis of migraine in adults who have at least four migraine days per month.3 Atogepant blocks the binding of the CGRP to the receptor and antagonises CGRP receptor function.3,15,17 CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology.3,15 Studies have shown that CGRP levels are elevated during migraine attacks15 and selective CGRP receptor antagonists confer clinical benefits in migraine.4,5,7 Error! Bookmark not defined.–,5,

About the atogepant Phase 3 clinical trial programme5,7,8

Atogepant was evaluated for the prophylaxis of migraine in three pivotal studies across the migraine spectrum in chronic and episodic migraine.

The data presented below for the ADVANCE and PROGRESS studies are from the modified intent-to-treat (mITT) population, as per the pre-specified analysis in the published studies. It therefore may differ slightly from the data in the AQUIPTA® Summary of Product Characteristics, which uses the off-treatment hypothetical estimand (OTHE) population at the request of the European Medicines Agency.

Episodic migraine5,8

ADVANCE Study5

Atogepant was evaluated for the prophylaxis of episodic migraine (4–14 headache days per month) in a randomised, multicentre, double-blind, placebo-controlled study (ADVANCE). A total of 910 patients were randomised 1:1:1:1 with N=222 to receive AQUIPTA® 60 mg and N=214 for placebo once daily for 12 weeks.

The primary efficacy endpoint was the change from baseline in mean monthly migraine days (MMD) across the 12-week treatment period. Additional endpoints included the change from baseline in mean monthly headache days, the change from baseline in mean monthly acute medication use days, the proportion of patients achieving at least a 50% and 75% reduction from baseline in mean MMD (3‑month average), and change from baseline at 12 weeks for Headache Impact Test HIT-6 total score and Migraine Specific Quality of Life Questionnaire version 2.1, MSQ v2.1 Role Function-Restrictive RFR domain score.

Atogepant demonstrated the following results (N=222 for atogepant and N=214 for placebo):

Primary efficacy endpoint

  • -4.2 days change from baseline (7.8 days) in mean MMD across 12 weeks compared to -2.5 with placebo from baseline (7.5 days), mean difference vs. placebo: -1.7, 95% CI -2.3 to -1.2, p<0.001

Secondary endpoints

  • -4.2 change from baseline (9.0 days) in mean monthly headache days across 12 weeks compared to -2.5 with placebo from baseline (8.4 days), mean difference vs. placebo: -1.7, 95% CI -2.3 to -1.1, p<0.001.
  • -3.9 days from baseline (6.9 days) of acute medication use per month for migraine attacks across 12 weeks compared to -2.4 days per month with placebo from baseline (6.5 days), mean difference vs. placebo: -1.5, 95% CI -2.0 to -1.0, p<0.001.
  • 135 patients achieved at least a 50% reduction from baseline in mean MMD across 12 weeks compared to 62 with placebo, odds ratio vs. placebo: 3.8, 95% CI 2.6 to 5.7, p<0.001.
  • +31.2 mean change in the effect of migraine on daily life and ability to function at work and social situations from baseline (46.8 days) in the MSQ v2.1 Role Function-Restrictive RFR at week 12 compared to +20.4 with placebo from baseline (46.8 days), difference vs. placebo: 10.8, 95% CI 6.4 to 15.2, p<0.001.
  • -9.1 mean change in quality of life from baseline (63.8 days) in the HIT-6 score at week 12 compared to -5.2 with placebo from baseline (64.6 days), difference vs. placebo: -3.9, 95% CI -5.4 to -2.5, p<0.001.3

For people with episodic migraine, who previously failed two to four classes of conventional oral medication used for prevention

ELEVATE Study8

Atogepant was evaluated for the preventive treatment of episodic migraine (4–14 headache days per month) in a randomised, double-blind, placebo-controlled, parallel-group, phase 3b trial in adults who had previously been failed by two to four classes of conventional oral preventive treatments. A total of 315 participants were included with N=156 to receive atogepant 60 mg and N=157 for placebo once daily for 12 weeks.

The primary efficacy endpoint was the change from baseline in mean MMDs (3-month average) across the 12-week treatment period in the OTHE population. Secondary endpoints included the achievement of ≥50% reduction in 3-month average of monthly migraine days, change from baseline in mean monthly headache days and change from baseline in mean monthly acute medication use days across 12 weeks.

Atogepant demonstrated the following results for the OTHE population (N=154 for atogepant and N=155 for placebo):

Primary endpoint

  • -4.2 days change from baseline (9.1 days) in mean MMD across 12 weeks compared to -1.9 days with placebo from baseline (9.3 days), mean difference vs. placebo: -2.4, 95% CI -3.2 to -1.5, p<0.0001.

Secondary endpoints

  • +78 (51%) reduction in 3-month average of monthly migraine days ≥50% compared to +28 (18%) with placebo, mean difference vs. placebo: +4.8, 95% CI 2.9 to 8.1, p<0.0001
  • -4.1 days change from baseline (9.9 days) in mean monthly headache days across 12 weeks compared to -1.9 days with placebo from baseline (10.1 days), mean difference vs. placebo:
    -2.2, 95% CI -3.1 to -1.3, p<0.0001.
  • -3.7 days change in monthly acute medication use from baseline (7.5 days) across 12 weeks compared to -1.1 days with placebo from baseline (7.7 days), mean difference vs. placebo: -2.6, 95% CI -3.4 to -1.9, p<0.0001.

Chronic migraine7

Atogepant was evaluated for the prophylaxis of chronic migraine (15 or more headache days with at least eight migraine days) in a randomised, multicentre, double-blind, placebo-controlled study (PROGRESS). A total of 778 patients were randomised 1:1:1 with N=256 to receive AQUIPTA® 60 mg and N=246 for placebo once daily for 12 weeks.

The primary efficacy endpoint was the change from baseline in mean MMD across the 12‑week treatment period. Additional endpoints included the change from baseline in mean monthly headache days, the change from baseline in mean monthly acute medication use days, the proportion of patients achieving at least a 50% and 75% reduction from baseline in mean MMD (3-month average) and change from baseline at week 12 for HIT-6 total score and MSQ v2.1 RFR domain score.

Atogepant demonstrated the following results (N=256 for atogepant and N=246 for placebo):

Primary endpoint

  • -6.9 days change from baseline (19.2 days) in mean MMD across 12 weeks compared to -5.1 days with placebo from baseline (18.9 days), mean difference vs. placebo: -1.8, 95% CI -2.9 to -0.8), p=0.0009.

Secondary endpoints

  • -7.0 days change from baseline (21.5 days) in mean monthly headache days across 12 weeks compared to -5.1 days with placebo from baseline (21.4 days), mean difference vs. placebo: -1.9, 95% CI -2.9 to -0.8, p=0.0009.
  • -6.2 days of acute medication use per month from baseline (15.5 days) for migraine attacks across 12 weeks compared to -4.1 days per month with placebo from baseline (15.4 days), mean difference vs. placebo: -2.1, 95% CI -3.1 to -1.1, p=0.0009.
  • +23.3 mean change in the effect of migraine on daily life and ability to function at work and social situations from baseline (43.6 days) in the MSQ v2.1 RFR at week 12 compared to +17.2 mean change with placebo from baseline (43.6 days), mean difference vs. placebo: 6.1, 95% CI 2.5 to 9.8, p=0.0009.
  • -7.8 mean change from baseline in quality of life from baseline (64.2) in the HIT-6 score at week 12 compared to -5.2 with placebo from baseline (64.0), difference vs. placebo: -2.7, 95% CI -4.0 to -1.3, p<0.0024.

Safety profile in ADVANCE and PROGRESS3

The safety profile of atogepant was evaluated in 2,657 patients with migraine who received at least one dose of atogepant. Of these, 1,225 patients were exposed to atogepant for at least six months and 826 patients were exposed for 12 months.

The most commonly reported adverse drug reactions were nausea (7%), constipation (7%), and fatigue/somnolence (5%). The majority of the cases were mild, and none were serious. The adverse reaction that most commonly led to discontinuation was nausea (0.6%).

Safety profile in ELEVATE8

The safety profile of atogepant was evaluated in 315 participants with migraine who took part in the study. The most common treatment-emergent adverse event with atogepant was constipation in 16 (10%) of 156 participants. Serious adverse events occurred in +4 (3%) of 156 participants in the atogepant group, and treatment-emergent adverse events resulting in treatment discontinuation occurred in 3 (2%) in the atogepant group.

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, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on X (formerly Twitter) or YouTube.

References

Clicking the links below will take you to external websites that are not managed or owned by AbbVie.

1. National Institute for Health and Care Excellence. Atogepant for preventing migraine. Available from: https://www.nice.org.uk/guidance/indevelopment/gid-ta10992 [Last accessed: March 2024].

2. Scottish Medicines Consortium. Atogepant (Aquipta). Available from: https://www.scottishmedicines.org.uk/medicines-advice/atogepant-aquipta-abbreviated-smc2599/ [Last accessed: March 2024].

3. AQUIPTA® (Atogepant) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/search?q=atogepant [Last accessed: March 2024].

4. Ashina M, et al. Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. Headache. 2023 Jan;63(1):79–88.

5. Ailani J, et al. Atogepant for the Preventive Treatment of Migraine. N Engl J Med. 2021;385:695–706.

6. Lipton RB, et al. Effect of atogepant for preventive migraine treatment on patient-reported outcomes in the randomized, double-blind, phase 3 ADVANCE trial. Neurology. 2023 Feb 21;100(8):e764–e777.

7. Pozo-Rosich P, et al. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785.

8. Tassorelli C, et al. Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial. Lancet Neurol. 2024 Feb;DOI: https://doi.org/10.1016/S1474-4422(24)00025-5.

9. The Migraine Trust. What is a migraine? Available from: https://migrainetrust.org/understand-migraine/what-is-migraine/. [Last accessed: March 2024].

10. The Migraine Trust. Heading in the wrong direction: Challenges in migraine care and why people with migraine deserve better. Available from: https://migrainetrust.org/wp-content/uploads/2023/09/TMT-Heading-In-The-Wrong-Direction-2023-FINAL.pdf [Last accessed: March 2024].

11. National Migraine Centre. What is migraine? Available from: https://www.nationalmigrainecentre.org.uk/understanding-migraine/what-is-migraine/ [Last accessed: March 2024].

12. The Migraine Trust. State of the Migraine Nation Dismissed for too long: Recommendations to improve migraine care in the UK. Available from: https://migrainetrust.org/wp-content/uploads/2021/09/Dismissed-for-too-long_Recommendations-to-improve-migraine-care-in-the-UK.pdf  [Last accessed: March 2024].

13. Begasse de Dhaem O and Sakai F. Migraine in the workplace. eNeurologicalSci. 2022 Jun 6;27:100408.

14. Gupta J and Gaurkar SS. Migraine: An Underestimated Neurological Condition Affecting Billions. Cureus. 2022 Aug 24;14(8):e28347.

15. Ferrari MD, et al. Migraine. Nat Rev Dis Primers. 2022;8(1):2.

16. The Work Foundation. Society’s headache. The socioeconomic impact of migraine: Available from: https://www.lancaster.ac.uk/media/lancaster-university/content-assets/documents/lums/work-foundation/SocietysHeadacheTheSocioeconomicimpactofmigraine.pdf. [Last accessed: March 2024].

17. Negro A and Martelletti P. Gepants for the treatment of migraine. Expert Opin Investig Drugs. 2019 Jun;28(6):555–567.

UK-ATP-240009 | Date of prep: April 2024

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