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

• The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA^® (atogepant), the oral, once-daily calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) as an option in suitable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 9^thOctober 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AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance (FDG) recommending AQUIPTA^® (atogepant), as an option for preventing migraine in adults who have at least 4 migraine days per month, only if at least 3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 9^th 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.^3-8 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,^3,6-8 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.”

▼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.