INDIANAPOLIS, June 15, 2021 /PRNewswire/ -- To
advance the science of migraine treatment and aid the understanding
of calcitonin gene-related peptide (CGRP) monoclonal antibodies
(mAbs) compared to oral CGRP receptor antagonists in the prevention
of migraine, Eli Lilly and Company (NYSE: LLY) will be
conducting a head-to-head study comparing once-monthly injectable
Emgality® (galcanezumab-gnlm) with
Nurtec® ODT (rimegepant), an orally
disintegrating tablet patients take every other day. CGRP is a
protein in the brain thought to play a key role in migraine.
Emgality binds to this protein, preventing it from attaching to the
CGRP receptors, whereas Nurtec ODT blocks the receptor for this
protein.1-3 This study aims to answer important
questions that will help clinicians and patients make more informed
treatment decisions on the path to more migraine-free days.
The study, which is the first head-to-head clinical trial
comparing two medications targeting CGRP, is a multi-site,
randomized, double-blind, double-dummy, parallel-group Phase 4
study in patients who meet the International Classification of
Headache Disorders (ICHD) criteria for a diagnosis of episodic
migraine with or without aura. There will be two treatment arms:
Emgality 120 mg once-monthly injection, with an initial 240 mg
loading dose, and Nurtec ODT 75 mg, taken every other day. The
study's primary endpoint is 50% reduction in monthly migraine
headache days. Enrollment is expected to begin later this year.
"Migraine is a painful, burdensome and complex neurologic
disease. Every person's experience is different. Providing patients
with options and individualized treatment plans is vitally
important," said Ilya Yuffa, senior
vice president and president, Lilly Bio-Medicines. "We are
confident in Emgality's efficacy profile and that our head-to-head
clinical trial against Nurtec ODT will yield valuable insights for
patients and their healthcare providers."
Emgality is the only CGRP therapy that includes ≥50%, ≥75% and
100% reduction in monthly migraine headache days for the duration
of the treatment period for episodic migraine patients, in its
FDA-approved labeling. Emgality's adherence and persistence
findings were recently presented at
AHS, and insights about interictal burden (impact of
migraine between migraine attacks) were shared previously.
"The American Headache Society and the National Headache
Foundation have endorsed several goals that raise the treatment
outcomes bar for preventive migraine medications. Patients tell us
they want an easy and convenient migraine treatment that can help
them be productive and free to focus on what matters most to them.
In order for patients to manage their own disease and have a sense
of personal control, they need to find treatments that work for
them that they can stay on. Reducing the number of days patients
experience migraine is possible and it's important that patients
and their HCPs talk about this as a goal," said Dr. Merle Diamond, managing director of the Diamond
Headache Clinic and longstanding board member of the National
Headache Foundation. "Undertaking this head-to-head study signals
Lilly's confidence in Emgality, a once-monthly injectable
monoclonal antibody CGRP antagonist (CGRP mAb), as it compares to
Nurtec ODT, a small molecule oral CGRP receptor antagonist
(gepant), for the prevention of migraine."
"This year, we are proud to help more than 700,000 Emgality
patients. We encourage HCPs and patients to talk about the
preventive treatment goal of freedom from migraine through
reduced frequency of attacks, which can also result in greater
quality of life and functional improvements. We believe
people should expect more and get more from their migraine
medications," said Yuffa. "We're looking forward to commencing the
study later this year and sharing our results."
About Emgality
Emgality is a monoclonal antibody that
selectively binds to calcitonin gene-related peptide (CGRP) and was
approved by the FDA in September 2018 for the preventive
treatment of migraine in adults. Emgality is the only CGRP
monoclonal antibody with response rates in the episodic migraine
headache population on ≥50%, ≥75% and 100% reduction from baseline
in monthly migraine headache days over Months 1 to 6 included in
its Full Prescribing Information. In June 2019, Emgality
was approved by the FDA for the treatment of episodic cluster
headache in adults.
Indications and Usage for Emgality (galcanezumab-gnlm) 120 mg
Injection
Emgality is a calcitonin gene-related peptide
(CGRP) antagonist indicated in adults for the:
- preventive treatment of migraine
- treatment of episodic cluster headache
Important Safety Information for
Emgality
Contraindications
Emgality is
contraindicated in patients with serious hypersensitivity to
galcanezumab-gnlm or to any of the excipients.
Warnings and Precautions
Hypersensitivity
Reactions
Hypersensitivity reactions, including dyspnea,
urticaria, and rash, have occurred with Emgality in clinical
studies and the postmarketing setting. Cases of anaphylaxis and
angioedema have also been reported in the postmarketing setting. If
a serious or severe hypersensitivity reaction occurs, discontinue
administration of Emgality and initiate appropriate therapy.
Hypersensitivity reactions can occur days after administration and
may be prolonged.
Adverse Reactions
The most common adverse reactions
(incidence ≥2% and at least 2% greater than placebo) in Emgality
clinical studies were injection site reactions.
Please see Full Prescribing Information,
including Patient Information, for Emgality. See
Instructions for Use included with the device.
GZ HCP ISI 10DEC2019
About Migraine
Migraine is a severely disabling
neurologic disease characterized by recurrent episodes of moderate
to severe headache accompanied by other symptoms including nausea,
sensitivity to light, and sensitivity to sound.4,5 More
than 30 million American adults have migraine, with three times
more women than men affected by migraine.6 Migraine is
often incapacitating, leading to high personal, societal and
economic burden. According to the Medical Expenditures Panel
Survey, total annual healthcare costs associated with migraine are
estimated to be as high as $56
billion in the United
States, yet it remains under-recognized and
under-treated.7
About Lilly's Commitment to Headache Disorders
For
over 25 years, Lilly has been committed to helping people affected
by headache disorders, investigating more than a dozen different
compounds for the treatment of migraine and cluster headache. These
research programs have accelerated our understanding of these
diseases and furthered the advancement of treatments for headache
disorders. Our goal is to apply our combined clinical, academic and
professional experience to build a research portfolio that delivers
broad solutions and addresses the needs of people affected by these
disabling neurologic diseases.
About Eli Lilly and Company
Lilly is a global health
care leader that unites caring with discovery to create medicines
that make life better for people around the world. We were founded
more than a century ago by a man committed to creating high-quality
medicines that meet real needs, and today we remain true to that
mission in all our work. Across the globe, Lilly employees work to
discover and bring life-changing medicines to those who need them,
improve the understanding and management of disease, and give back
to communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at lilly.com and
lilly.com/newsroom. P-LLY
Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Emgality (galcanezumab-gnlm) as a preventive treatment
for patients with migraine and as a treatment for patients with
episodic cluster headache, and reflects Lilly's current beliefs and
expectations. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of drug
research, development and commercialization. Among other things,
there can be no guarantee that planned or ongoing studies will be
completed as planned, that future study results will be consistent
with the results to date, or that Emgality will receive any
additional regulatory approvals or be commercially successful. For
further discussion of these and other risks and uncertainties, see
Lilly's most recent Form 10-K and Form 10-Q filings with the United
States Securities and Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking statements
to reflect events after the date of this release.
Emgality® is a registered trademark owned or licensed
by Eli Lilly and Company, its subsidiaries, or affiliates. All
non-Lilly products referenced are the trademarks of their
respective owners.
References:
- Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
- Russo AF. Calcitonin gene-related peptide (CGRP): a new target
for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
- Garza I, Swanson JW. Prophylaxis of migraine. Neuropsychiatr
Dis Treat. 2006;2(3):281-291.
- Katsarava Z, Buse D, Manack A, et al. Defining the differences
between episodic migraine and chronic migraine. Current Pain
Headache Reports. 2012;16:86.
- Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL,
and resource use amongst chronic and episodic migraineurs. Results
from the International Burden of Migraine Study (IBMS).
Cephalalgia. 2011;31:301.
- Lipton RB, Bigal ME, Diamond M, et al., Migraine prevalence,
disease burden, and the need for preventive therapy. Neurology.
2007;68:343-349.
- Raval AD, Shah A. National trends in direct health
care expenditures among U.S. adults with migraine: 2004
to 2013. Journal of Pain. 2017;57:60.
Copyright © 2021 Eli Lilly and Company. All
rights reserved.
Refer
to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
|
|
Kevin
Hern; hern_kevin_r@lilly.com; 317-277-1838 (Investor
Relations)
|
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