- If approved by the European Commission (EC), atogepant will
be the first and only once daily oral calcitonin gene-related
peptide (CGRP) receptor antagonist (gepant) in the European Union
(EU) for the prophylaxis of migraine in adults who have four or
more migraine days per month
- The positive CHMP opinion is based on results from two
pivotal Phase 3 studies evaluating atogepant for the prophylaxis of
migraine in adults with episodic or chronic migraine
NORTH
CHICAGO, Ill., June 23,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion recommending the approval of atogepant for the prophylaxis
of migraine in adults who have four or more migraine days per
month. If approved, AbbVie will be the only company to offer a once
daily oral calcitonin gene-related peptide (CGRP) receptor
antagonist (gepant) treatment spanning both episodic and chronic
migraine in the European Union (EU).
Chronic migraine (CM) is characterized by 15 or more headache
days a month and at least eight migraine days, while episodic
migraine (EM) refers to people with migraine who have less than 15
headache days per month.1 In Europe, migraine is estimated to cost the
economy €50 billion annually due to reduced productivity and
workdays lost.2
"Migraine is a complex neurological disease and one of the
leading causes of disability worldwide, which is why we continue to
advance our science to provide effective treatment options for
people living with this debilitating condition," said Dawn Carlson, vice president, neuroscience
development, AbbVie. "The recent positive CHMP opinion of atogepant
brings us closer to providing a new therapy option to those living
with migraine in the European Union."
The positive CHMP opinion for atogepant is supported by data
from two pivotal Phase 3 studies, PROGRESS and ADVANCE, which
evaluated 60 mg once daily (QD) atogepant in adult patients with
chronic and episodic migraine, respectively. Both studies met their
primary endpoint of a statistically significant reduction in mean
monthly migraine days (MMDs), compared to placebo across the
12-week treatment period. Additionally, statistically significant
improvements were seen in all secondary endpoints with atogepant 60
mg QD.3,4
In the PROGRESS study, the changes from baseline in MMDs were
−6.8 days for atogepant 60 mg QD and -5.1 days for placebo
(p=0.0024).3 In the ADVANCE study, the changes from
baseline in MMDs were −4.1 days for atogepant 60 mg QD and −2.5
days for placebo (p=<0.001).4 In both studies,
atogepant 60 mg QD was well tolerated and the most common adverse
events were constipation, nausea, and fatigue. The adverse drug
reaction most commonly leading to study discontinuation was nausea
(0.4%).3,4
"Far too many people around the world are impacted by migraine,
and the path to treatment can be long and complex," said Prof.
Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall
d'Hebron Hospital and Institute of Research, Spain. "The approval of atogepant would
represent a meaningful advancement for the migraine community in
the European Union, providing adults with four or more migraine
days per month a new prophylactic treatment option that offers the
possibility of sustained migraine prevention."
Migraine is highly prevalent, affecting 1 billion people
worldwide5, including an estimated 41 million people in
Europe.6 Individuals
with migraine experience frequent disabling migraine attacks,
preventing them from performing daily activities and significantly
affecting their quality of life.7 This debilitating
disease imposes both a social and financial burden for people
living with migraine and healthcare systems.8
About Atogepant
Atogepant is an orally administered, CGRP receptor antagonist
specifically developed for the preventive treatment of migraine in
adults who have four or more migraine days per month. CGRP and its
receptors are expressed in regions of the nervous system associated
with migraine pathophysiology. Studies have shown that CGRP levels
are elevated during migraine attacks and selective CGRP receptor
antagonists confer clinical benefit in migraine.
About the Phase 3 PROGRESS Clinical
Trial3
The pivotal Phase 3 PROGRESS study
evaluated the safety, tolerability, and efficacy of oral atogepant
for the prophylaxis of chronic migraine compared with placebo. The
study included 778 patients with a diagnosis of chronic
migraine for at least one year, and greater or equal to
15 headache days with at least eight migraine days
in the 28 days prior. Patients were randomized into one of three
treatment groups receiving 60 mg QD of atogepant, 30 mg twice daily
of atogepant, or placebo. The primary endpoint measured the
reduction from baseline in MMDs compared to placebo for 60 mg QD
across a 12-week treatment period (p=0.0024). The overall safety
profile observed in the Phase 3 PROGRESS study was consistent with
safety findings observed in previous studies. The most common
adverse events reported with a frequency greater than or equal to
5% in the atogepant 60 mg QD arm were constipation (10.0% vs. 3.1%
for placebo) and nausea (9.6% vs. 3.5% for placebo). Most of the
events of constipation and nausea were mild or moderate in severity
and did not lead to study discontinuation.
Additional key secondary endpoints included change from baseline
in mean monthly headache days (MHDs), change from baseline in mean
monthly acute-medication use, proportion of participants with at
least a 50% reduction in MMDs across the 12-week treatment period
and change from baseline in Migraine-Specific Quality-of-Life
Questionnaire Version 2.1 (MSQ v2.1) Role Function-Restrictive
(RFR) domain score at week 12. MSQ v2.1 is designed to measure
health-related quality of life impairments attributed to
migraine.
For a full listing of secondary endpoints across all regions,
please go to www.clinicaltrials.gov (NCT03855137).
About the Phase 3 ADVANCE Clinical Trial4
The pivotal Phase 3 ADVANCE study evaluated the efficacy, safety,
and tolerability of oral atogepant for the prevention of migraine
in those with 4 to 14 migraine days per month. A total of 910
patients were randomized to one of four treatment groups evaluating
10 mg, 30 mg, or 60 mg of atogepant QD, or placebo. The primary
endpoint was change from baseline in MMDs compared to placebo for
60 mg QD across a 12-week treatment period (p<0.001). The
study demonstrated that treatment with atogepant 60 mg QD resulted
in statistically significant improvements in all the primary and
secondary endpoints. The most common adverse events reported with a
frequency greater than or equal to 5% in the atogepant 60 mg QD arm
were constipation (6.9% vs. 0.5% for placebo), nausea (6.1% vs.
1.8% for placebo), and upper respiratory tract infection (3.9% vs.
4.5% for placebo). Most of the events of constipation and
nausea were mild or moderate in severity and did not lead to study
discontinuation.
Additional key secondary endpoints included change from baseline
in MHDs, mean monthly acute-medication use days, and mean monthly
performance of daily activities and physical impairment domain
scores of the Activity Impairment in Migraine-Diary (AIM-D)
across the 12-week treatment period, and change from baseline in
the MSQ v2.1 RFR domain score at week 12. The AIM-D is a
questionnaire designed to evaluate difficulty with performance of
daily activities and physical impairment due to migraine.
For a full listing of secondary endpoints across all regions,
please go to www.clinicaltrials.gov (NCT03777059).
About AbbVie in Neuroscience
At AbbVie, our
commitment to preserving 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. For more information, visit
www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
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, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @AbbVie on Twitter,
Facebook, Instagram, YouTube, and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions and uses of future
or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2022 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
References
1 Curr Pain Headache Rep. 2012; 16(1): 86–92.
2 Rethinking Migraine in times of COVID-19. European
Brain Council. 2023.
https://www.braincouncil.eu/projects/rethinking-migraine/. Accessed
June 2023.
3 AbbVie. Data on File: ABVRRTI76375
4 Ailani J, et al. NEJM. Atogepant for the Preventive
Treatment of Migraine. 2021; 385:695-706. DOI:
10.1056/NEJMoa2035908.
5 Global Burden of Disease Study. 2016. Lancet Neurology
2018;17:954–76.
6 Rethinking Migraine in times of COVID-19. European
Brain Council. 2023. Available at:
https://www.braincouncil.eu/projects/rethinking-migraine/. Accessed
May 31, 2023.
7 Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality
of life impairment, disability and economic burden associated with
chronic daily headache, focusing on chronic migraine with or
without medication overuse: a systematic review. Cephalalgia.
2011;31:837-850.
8 Messali A, Sanderson JC, Blumenfeld AM, et al. Direct
and indirect costs of chronic and episodic migraine in the United States: a web-based survey.
Headache. 2016;56:306-322.
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