- Interim analysis of an
ongoing 156-week extension study supports long-term safety,
tolerability and efficacy of atogepant 60 mg to prevent chronic
and episodic migraine
- Seventy
percent of subjects achieved ≥50% reduction in monthly migraine
days at Weeks 13-16 and this was consistent during the 48 weeks of
open-label treatment
- Findings
will be showcased in an oral presentation at the American Academy
of Neurology (AAN) Annual Meeting Scientific Platform Session for
Emerging Science
NORTH
CHICAGO, Ill., April 12,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced an interim analysis of an ongoing Phase 3, open-label
156-week extension study evaluating the long-term safety and
tolerability of oral atogepant for the prevention of migraine in
participants with chronic or episodic migraine. The overall
long-term safety results were consistent with the known safety
profile of atogepant in chronic and episodic migraine, and no new
safety signals were identified. These results also support
improvements in key efficacy outcomes, including reduction in
monthly acute medication use days.
"Migraine is a debilitating neurological disease that can have a
significant impact on day-to-day life," said Sait Ashina, MD, assistant professor of
neurology and anesthesia at Harvard Medical
School, director of the Comprehensive Headache Center at
Beth Israel Deaconess Medical Center in Boston, and lead author of the study. "As the
first report of one-year atogepant data in patients with chronic
migraine, this builds on the long-term observed safety and efficacy
in the episodic migraine population and demonstrates atogepant's
ability to reduce migraine days and acute medication use across the
spectrum of the disease."
The extension study included participants who had enrolled in
the Phase 3 PROGRESS and ELEVATE clinical trials with a baseline
monthly migraine day burden of 14.5 days and completed these
studies. Key findings from the interim analysis include:
- Monthly migraine days improved on average by 8.5 days at Weeks
13-16 and this was consistent over 48 weeks. Similar improvements
were observed for monthly headache days and monthly acute
medication use days.
- Seventy percent of subjects achieved ≥50% reduction in monthly
migraine days at Weeks 13-16 and this was consistent during the 48
weeks of open-label treatment.
- Overall safety results were consistent with the known safety
profile of atogepant 60 mg, and no new safety signals were
identified.
- The most common treatment-emergent adverse events (≥5%) were
COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation
(8.2%).
"We understand that migraine is a complex disease and AbbVie is
steadfast in our commitment to alleviating the considerable burden
facing migraine patients," said Dawn
Carlson, vice president, neuroscience development, AbbVie.
"Patients should accept nothing less than migraine freedom, and the
long-term safety and efficacy shown in this interim analysis marks
another step toward that goal."
Atogepant, also known as QULIPTA® in the U.S. and
AQUIPTA® in the European Union (EU), is approved in 45
countries. It is an oral calcitonin gene-related peptide (CGRP)
receptor antagonist proven to prevent both episodic and chronic
migraine in adults.
AbbVie will continue to pursue additional regulatory submissions
for atogepant across international markets.
About Study 3101-312-002
Study 3101-312-002 is an
ongoing Phase 3, multicenter, open-label 156-week extension study
evaluating the long-term safety and tolerability of oral atogepant
for the prevention of migraine in participants with chronic or
episodic migraine. The primary objective was to evaluate safety and
tolerability in all participants who received ≥1 dose of study
intervention in the extension study (N = 595). Efficacy was
evaluated by eDiary at Weeks 13-16, 29-32 and 45-48. The modified
intention-to-treat population included participants who received ≥1
dose of atogepant and had ≥1 evaluable post-baseline 4-week period
of eDiary data (N=524). Pre-specified efficacy endpoints included
in the late-breaking data included change from baseline in monthly
migraine days, monthly headache days, monthly acute medication use
days and the proportion of participants with ≥ 50% improvement in
monthly migraine days. The current interim analysis was performed
after all study participants completed the efficacy data collection
portion of the study at Week 52 or early termination. More
information can be found on
www.clinicaltrials.gov (NCT04686136).
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 have been failed by
two to four classes of oral preventive 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 mean
monthly headache days (MHDs), and change from baseline in acute
medication use days across 12 weeks. More information can be found
on www.clinicaltrials.gov (NCT04740827).
About the PROGRESS Study
The PROGRESS study was a global, randomized, double-blind,
placebo-controlled Phase 3 trial assessing the efficacy, safety,
and tolerability of atogepant for the preventive treatment of
chronic migraine. Adults with a 1-year or longer history of chronic
migraine were randomly assigned (1:1:1) to receive oral atogepant
30 mg twice a day (not a U.S. FDA-approved dose), oral atogepant 60
mg once a day, or placebo. The primary endpoint was change from
baseline in mean monthly migraine days (MMDs) across the 12-week
treatment period. Key secondary endpoints for all
regions included proportion of participants with at least a
50% reduction in MMDs across the 12-week treatment period, change
from baseline in mean monthly headache days (MHDs) across the
12-week treatment period, and change from baseline in mean monthly
acute medication use days across the 12-week treatment period. More
information can be found on www.clinicaltrials.gov
(NCT03855137).
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.
Atogepant, known as AQUIPTA® in the European Union,
was approved by the European Commission in August 2023 for the prevention of episodic or
chronic migraine in adults with 4 or more monthly migraine days
(MMDs).
IMPORTANT SAFETY INFORMATION
Do not take QULIPTA if you have had an allergic reaction to
atogepant or any ingredients in QULIPTA.
Before taking QULIPTA, 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 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.
QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.
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 Migraine and Chronic Migraine
Migraine is a
complex neurological disease with recurrent attacks that are often
incapacitating and characterized by severe, throbbing headache pain
as well as compounding associated symptoms like extreme sensitivity
to light, sound or nausea.1 It is highly prevalent,
affecting more than 1 billion people worldwide, including nearly 40
million people in the United States alone, and is the
highest cause of disability worldwide for people under 50 years of
age.2-5
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.6 It is
differentiated from episodic migraine, which is characterized by
0-14 headache days per month,7 by its more
debilitating disease profile including greater prevalence of
comorbid conditions as well as higher frequency of headache and
migraine days.7-9 Individuals with chronic migraine
experience frequent disabling migraine attacks, preventing them
from performing daily activities and significantly affecting their
quality of life. This results in substantial societal and familial
burden.10-14 Significant direct and indirect costs are
also associated with chronic migraine, leading to economic burden
for patients and healthcare systems.15-17
About AbbVie in Migraine
AbbVie is the only company
with three prescription treatments designed to meet patient needs
across the full spectrum of migraine to help patients living with
this debilitating disease.
At AbbVie, we are committed to empowering people living with
migraine disease. We advance science that enables healthcare
providers to care for people impacted across the spectrum of
migraine. Through education and partnerships with the migraine
community, we strive to help those with migraine navigate barriers
to care, access effective treatments and reduce the impact of
migraine on their lives.
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
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.com. Follow
@abbvie on LinkedIn, Facebook, Instagram, X
(formerly Twitter), and YouTube.
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 2023 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.
US-QLP-240094
References:
- Headache Classification Committee of the International Headache
Society (IHS) The International Classification of Headache
Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R,
Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S.
Migraine: A Review on Its History, Global Epidemiology, Risk
Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605.
doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID:
PMC8904749.
- Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., &
Katsarava, Z. Migraine is first cause of disability in under 50s:
Will health politicians now take notice? J Headache Pain.
2018;19:17.
- AbbVie. Data on File: ABVRRTI73750
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the
differences between episodic migraine and chronic migraine. Curr
Pain Headache Rep. 2012;16:86-92.
- Headache Classification Committee of the International Headache
Society (IHS) The International Classification of Headache
Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the
differences between episodic migraine and chronic migraine. Curr
Pain Headache Rep. 2012;16:86-92.
- Buse DC, Manack A, Serrano DC, et al. Sociodemographic and
comorbidity profiles of chronic migraine and episodic migraine
sufferers. J Neurol Neurosurg Psychiatry. 2010;81:428-432.
- Adams AM, Serrano D, Buse DC, et al. The impact of chronic
migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO)
Study methods and baseline results. Cephalalgia. 2015;35(7)
563-578.
- Blumenfeld A, Varon S, Wilcox TK, et al. Disability, HRQoL and
resource use among chronic and episodic migraineurs: results from
the International Burden of Migraine Study (IBMS). Cephalalgia.
2011;31:301-315.
- 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.
- Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the
family: perspectives of people with migraine and their
spouse/domestic partner in the CaMEO Study. Mayo Clin Proc. 2016;91:596-611.
- Buse DC, Powers SW, Gelfand AA, et al. Adolescent perspectives
on the burden of a parent's migraine: results from the CaMEO study.
Headache. 2018;58:512-524.
- Buse DC, Murray S, Dumas PK, et al. Life with migraine, effect
on relationships, career and finances, and overall health and
well-being results of the Chronic Migraine Epidemiology and
Outcomes (CaMEO) Study. Cephalalgia. 2018;38(Suppl 1):9-10.
- 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.
- Sanderson JC, Devine EB, Lipton RB, et al. Headache-related
health resource utilization in chronic and episodic migraine across
six countries. J Neurol Neurosurg Psychiatry.
2013;84:1309-1317.
- Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL
and resource use among chronic and episodic migraineurs: Results
from the International Burden of Migraine Study (IBMS).
Cephalalgia. 2011;31:301-315.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/abbvie-announces-late-breaking-data-at-aan-supporting-long-term-safety-and-efficacy-of-atogepant-qulipta-for-preventive-treatment-of-migraine-302114992.html
SOURCE AbbVie