- The Phase 3 ELEVATE study demonstrated atogepant is
effective and well-tolerated for the preventive treatment of
episodic migraine in people who previously failed two to four
classes of conventional oral medications used for
prevention
- The trial met its primary and secondary endpoints with
results showcasing a significant reduction in mean monthly migraine
days for those with episodic migraine taking atogepant 60 mg once
daily compared to placebo across a 12-week period
- Data will be presented as part of an oral and poster
presentation during the AAN Scientific Platform Session for
Emerging Science
NORTH
CHICAGO, Ill., April 21,
2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced positive data from its Phase 3 ELEVATE study, evaluating
atogepant for the preventive treatment of episodic migraine in
people who had previously failed two to four classes of oral
preventive medications. The results of the study demonstrated adult
patients in the atogepant 60 mg once daily (QD) arm experienced a
decrease of 4.20 days in their mean monthly migraine days (MMDs)
across the 12-week treatment period, which was statistically
significantly greater than the 1.85 day reduction observed in the
placebo arm (p<0.0001). The data will be presented during
the Emerging Science session on Tuesday,
April 25, at the 2023 American Academy of Neurology (AAN)
Annual Meeting taking place in Boston,
Massachusetts.
"We understand that people living with migraine endure a chronic
neurological disease and we are dedicated to providing them the
best chance to live a life with less frequent migraines," said
Dawn Carlson, vice president,
neuroscience development, AbbVie. "The data presented at AAN
underscores the important role of atogepant, not only as a
treatment option for people living with episodic migraine but also
for those whose previous treatments failed to help reduce the
impact of migraine on their lives."
The ELEVATE study met all primary and secondary endpoints and
demonstrated a statistically significant reduction in MMDs for
those with episodic migraine taking atogepant 60 mg QD compared to
placebo. The primary endpoint was the change from baseline in mean
MMDs across 12 weeks and the secondary endpoints included
achievement of more than 50% reduction in MMDs, change from
baseline in MMDs, and change from baseline in acute medication use
days across 12 weeks.
A total of 309 participants were enrolled and of these
participants, 56% had previously failed two classes of oral
migraine preventive medications and 44% had previous failed three
or more classes, having discontinued them due to concerns with
efficacy or tolerability. The results demonstrated atogepant
60 mg QD was well tolerated and the safety results were consistent
with the known safety profile of atogepant. The most commonly
reported (≥5% in any treatment arm) treatment-emergent adverse
events (atogepant vs placebo, respectively) included constipation
(10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%),
and nasopharyngitis (5.1% vs 7.6%).
"For those living with migraine, the path towards effective
treatment can be a long and complex journey," said Prof.
Patricia Pozo-Rosich, MD, PhD, Head
of Neurology Section, Vall d'Hebron Hospital and Institute of
Research, Spain. "The ELEVATE
trial demonstrates atogepant as a once-daily oral treatment that
can significantly reduce monthly migraine days across a lifelong
disorder, allowing people to experience relief in their daily
lives, including those who have previously been failed by other
preventive migraine treatments."
Migraine is highly prevalent, affecting one billion people
worldwide,1 and is one of the highest causes of
disability for people under 50 years of age.2
Individuals with migraine experience frequent disabling migraine
attacks, preventing them from performing daily activities and
significantly affecting their quality of life.3 This
debilitating disease imposes both a social and financial burden
causing a significant burden for people living with migraine and
healthcare systems.4
The U.S. Food and Drug Administration recently approved
QULIPTA® as the first and only oral calcitonin
gene-related peptide (CGRP) receptor antagonist proven to prevent
both episodic and chronic migraine in adults in the United States. AbbVie will continue to
pursue regulatory submissions for atogepant across international
markets throughout the year.
About the ELEVATE Study
The ELEVATE study was a
global, randomized, double-blind, placebo-controlled trial
assessing the safety, tolerability, and efficacy of atogepant 60 mg
once daily (QD) compared with placebo for the preventive treatment
of episodic migraine in adult participants who previously failed
two to four classes of oral prophylactic treatments. The primary
endpoint was the change from baseline in mean monthly migraine days
(MMDs) across 12 weeks. Secondary endpoints included achievement of
more than 50% reduction in MMDs, change from baseline in MMDs, and
change from baseline in acute medication use days across 12 weeks.
More information can be found on www.clinicaltrials.gov
(NCT04740827).
About Atogepant (QULIPTA®)
Atogepant is an orally administered, CGRP receptor antagonist
specifically developed for the preventive treatment of migraine in
adults. 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. The use of atogepant in migraine is not approved in
the United Kingdom or European Union and its safety and
efficacy have not been evaluated.
U.S. Indications and Important Safety Information about
QULIPTA® (atogepant)
QULIPTA is a prescription medicine used for the preventive
treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Do not take QULIPTA if you have had an allergic reaction to
atogepant or any ingredients in QULIPTA.
Before taking QULIPTA® (atogepant) tablets,
tell your healthcare provider about all your medical conditions,
including if you:
- Have kidney problems or are on dialysis
- Have liver problems
- Are pregnant or plan to become pregnant. It is not known if
QULIPTA will harm your unborn baby
- Are breastfeeding or plan to breastfeed. It is not known if
QULIPTA passes into your breast milk. Talk to your healthcare
provider about the best way to feed your baby while taking
QULIPTA
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. QULIPTA may affect the way other
medicines work, and other medicines may affect how QULIPTA works.
Your healthcare provider may need to change the dose of QULIPTA
when taken with certain other medicines.
QULIPTA can cause serious allergic (hypersensitivity) reactions,
like anaphylaxis, that can happen when you take QULIPTA or days
after. Stop taking QULIPTA and get emergency medical help right
away if you get any of the following symptoms, which may be part of
a serious allergic reaction: swelling of the face, lips, or tongue;
itching; trouble breathing; hives; or rash.
The most common side effects of QULIPTA are nausea,
constipation, and fatigue/sleepiness. These are not all the
possible side effects of QULIPTA.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
Please see full Prescribing Information.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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 "The facts about migraine." Migraine Research
Foundation. Available at:
https://americanmigrainefoundation.org/resource-library/migraine-facts/.
Accessed: January 17, 2023.
2 Steiner, T.J., Stovner, L.J., Jensen, R., et al.
"Migraine remains second among the world's causes of disability,
and first among young women: findings from GBD2019." The J Headache
Pain 21, 137 (2020).
https://doi.org/10.1186/s10194-020-01208-0.
3 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.
4 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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