AbbVie’s AQUIPTA[®]▼ (atogepant) Is Now Available In Scotland For The Prevention Of Migraines In Adults

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

• The Scottish Medicines Consortium (SMC) has accepted AQUIPTA^® (atogepant), the oral, once-daily calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for restricted use within NHS Scotland.¹
• The decision follows the Medicines and Healthcare products Regulatory Agency (MHRA) granting the marketing authorisation of atogepant in Great Britain on 30^th August 2023 for the prophylaxis of migraine in adults who have at least four migraine days per month.²
• Atogepant demonstrated significant reduction in mean monthly migraine days from baseline across 12 weeks based on results from two pivotal Phase 3 studies.^2-6

MAIDENHEAD, UK, 9^th October 2023 — AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has accepted AQUIPTA^® (atogepant) for restricted use within NHS Scotland for the prophylaxis of migraine in adults who have at least four migraine days per month and for patients with chronic and episodic migraine who have had prior treatment failure on three or more migraine preventive treatments.¹ The decision comes via the SMC’s abbreviated (therapeutic class) process, following the marketing authorisation of atogepant by the MHRA.¹ This process is for medicines where alternatives within the same therapeutic class are already available for the same indication.

Migraine is a long-term health condition.⁷ In Scotland, it affects around 600,000 people⁸ and was the 7^th most common cause of disease burden in 2016.⁹ Symptoms are painful, severe and can affect the whole body.⁷ Migraine can have an impact on the health and wellbeing of patients,¹⁰ affecting their ability to work, socialise and care for dependents, along with having an impact on mental health.¹¹ This can leave some patients feeling that migraine controls and dictates their life.¹² The condition also has significant societal impact; it is currently under-diagnosed and not optimally treated,¹⁰ leading to a large number of patients using emergency services or being referred to outpatient neurology services for migraine care.^9,13 In 2020, over 35,000 people in Scotland were admitted to hospital due to migraine.¹⁴

“Migraine can significantly impact a person’s life and the people around them. For years, people have had to endure living with the condition without being able to find a suitable and effective treatment,” said Dr Alok Tyagi, Consultant Neurologist, Queen Elizabeth University Hospital, Glasgow. “The decision by the SMC on atogepant is an important step forward in increasing the number of treatment options that we can prescribe to eligible adults living with migraine, offering the potential to improve their quality of life.”

The SMC’s advice is supported by data from two pivotal Phase 3 clinical studies evaluating atogepant 60 mg once-daily in adults living with episodic (ADVANCE) and chronic (PROGRESS) migraine.^2-6 In both trials, the treatment met the primary endpoint of a change from baseline in mean monthly migraine days across 12 weeks vs. placebo. Additionally, the treatment achieved significant reductions from baseline in several secondary efficacy endpoints compared to placebo: mean monthly headache days and mean monthly acute medication days.^2,5,6 Atogepant was generally well tolerated, with the most commonly reported adverse reactions being nausea (7%), constipation (7%) and fatigue/somnolence (5%).² The majority of adverse events were mild, and none were serious.²

Belinda Byrne, Medical Director, AbbVie UK said: “The SMC are the first to accept atogepant on the NHS, ensuring people living with migraine in Scotland have timely access to a new treatment option. We know the significant impact migraine has, and the availability of atogepant now has the potential to improve lives for eligible patients with chronic or episodic migraine.”

-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 disabling primary headache disorder, typically involving recurrent moderate to severe pulsatile headaches and neurological symptoms.¹⁵ Migraine attacks can involve the whole body, with sensitivity to light, sounds and smells, nausea, and fatigue.¹⁶ It is highly prevalent, standing as the second highest cause of disability globally,¹⁵ 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.^2,17 It is differentiated from episodic migraine, which is characterised by 4–14 headache days per month,^2,17 greater prevalence of comorbid conditions, as well as higher frequency of headache and migraine days.¹⁷ Migraine can affect people’s ability to work, socialise and care for dependents, along with having an impact on mental health.¹⁸ Despite the prevalence and impact of migraine, it’s often under diagnosed and not optimally treated.¹⁸

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.² Atogepant blocks the binding of the CGRP to the receptor and antagonises CGRP receptor function.^2,17,19 CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology.^2,17 Studies have shown that CGRP levels are elevated during migraine attacks¹⁷ and selective CGRP receptor antagonists confer clinical benefits in migraine.^3,4,6–,5,

About the atogepant Phase 3 clinical trial programme^4,6

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

The data presented below 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 migraine⁴

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<0.001.²