INDIANAPOLIS, April 20, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) will highlight Phase 2 data evaluating
galcanezumab for the prevention of migraine at the American Academy
of Neurology (AAN) annual meeting, which will take place
April 22-28, 2017, in Boston.
Lilly will present four abstracts at AAN, including safety and
patient outcomes data for galcanezumab in patients with migraine
and factors associated with a reduction in monthly migraine
headache days among patients with episodic migraine. Lilly will
also highlight findings from U.S. healthcare claims data
identifying clinical characteristics and treatment patterns among
patients with cluster headache.
Galcanezumab is a once-monthly, subcutaneously injected
calcitonin gene-related peptide (CGRP) antibody currently being
studied as a potential treatment for the prevention of episodic and
chronic migraine and cluster headache. Galcanezumab is a monoclonal
antibody specifically designed to bind to and inhibit the activity
of CGRP that may prevent or significantly reduce the frequency of
monthly migraine headache days in patients with episodic and
chronic migraine and cluster headache.
"Migraine and cluster headaches are serious, neurological
diseases that have a significant physical and emotional impact on
not only people affected, but those with whom they interact at home
and at work," said Sheena Aurora,
M.D., medical fellow and global launch leader, galcanezumab, Eli
Lilly and Company. "Lilly is excited to present these galcanezumab
data, which further our understanding of these diseases and support
our decades-long effort to develop a targeted, preventive therapy
that can bring significant value to patients, including a
meaningful reduction in the number of days lost to
migraine."
Studies, as well as the dates and times of the data sessions,
are highlighted below.
Sunday, April 23 – 4:00-5:30 p.m. ET
- P1.181: Clinical Characteristics and Treatment Patterns
among Patients with Diagnostic Codes for Cluster Headache in the
U.S. Healthcare Claims Data
-
- Presenter: Casey Choong,
associate consultant, Eli Lilly & Company, Indianapolis, IN
Monday, April 24 – 5:30-7:00 p.m. ET
- P2.164: Hepatic Safety of Galcanezumab in Patients with
Migraine: Results of Three Phase 2 Double-Blind Placebo-Controlled
Trials
-
- Presenter: Vladimir Skljarevski,
M.D., medical fellow, Eli Lilly & Company, Indianapolis, IN
- P2.177: Factors Associated with Significant Reduction in
Migraine Headache Days: A Post-Hoc Analysis of a Phase 2
Placebo-Controlled Trial in Patients Treated with Galcanezumab
-
- Presenter: Sheena Aurora, M.D.,
medical fellow and global launch leader, galcanezumab, Eli Lilly
& Company, Indianapolis,
IN
- P2.179: Measures of Functioning Using MSQ v2.1 in
Patients with a History of Episodic Migraine and Treated with
Galcanezumab or Placebo Injections in a Phase 2 Clinical Trial
-
- Presenter: David Ayer, senior
research scientist, Eli Lilly & Company, Indianapolis, IN
Top-line results for galcanezumab for the treatment of migraine
are expected in 2017. Lilly plans to submit galcanezumab for
regulatory approval for migraine in the second half of 2017.
About Galcanezumab
Galcanezumab is a once-monthly,
subcutaneously injected calcitonin gene-related peptide (CGRP)
antibody currently being studied as a potential treatment for the
prevention of episodic and chronic migraine and cluster headache.
Galcanezumab is a monoclonal antibody specifically designed to bind
to and inhibit the activity of CGRP that may prevent or
significantly reduce the frequency of monthly migraine headache
days in patients with episodic and chronic migraine.
About Migraine
Migraine is a painful, neurological
disease characterized by recurrent episodes of severe headache, and
is often accompanied by other symptoms including nausea, vomiting,
sensitivity to light and sound, and changes in
vision.1,2 More than 38 million Americans have migraine,
with three times more women affected by migraine compared to
men.1,3 According to the Migraine Research Foundation,
healthcare and lost productivity costs associated with migraine are
estimated to be as high as $36
billion annually in the United
States,1 yet it remains under-recognized and
under-treated, with more than 40 percent of people going
undiagnosed.4
About Cluster Headache
Cluster headache, often
characterized as the most painful of all headaches, is a
neurological disease characterized by recurrent, severe headaches
on one side of the head, usually behind or around one
eye.2,5 Cluster headaches – commonly known as "attacks"
– typically last between 15 minutes to more than two hours and can
recur on the same day and occur daily to multiple times a day for
weeks or longer, followed by periods of time in which no attacks
occur.5 Cluster headache is classified as "chronic"
when attacks occur for more than one year without a remission
period, or with remission lasting less than one
month.5
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to 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 www.lilly.com and
www.lilly.com/newsroom/social-channels.
P-LLY
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about galcanezumab as a potential treatment for patients with
migraine and cluster headache and reflects Lilly's current belief.
However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. Among other things, there can be no
guarantee that future study results will be consistent with the
results to date or that galcanezumab will achieve its primary study
endpoints or receive regulatory approvals. 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.
1 Headache disorders. World Health Organization
website. http://www.who.int/mediacentre/factsheets/fs277/en/.
Accessed April 5, 2017.
2 Russo AF. Calcitonin gene-related peptide (CGRP): a
new target for migraine. Annual Review of Pharmacology and
Toxicology. 2015;55:533-552.
3 Identifying and treating migraine. American Migraine
Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/identifying-treating-migraine/.
Accessed April 19, 2017.
4 Diamond S, Bigal ME, Silberstein S, et al. Patterns of
diagnosis and acute and preventive treatment for migraine in
the United States: results from
the American Prevalence and Prevention study. Headache.
2007;47(3):355-363.
5 Treatment for cluster headache. American Migraine
Foundation website.
https://americanmigrainefoundation.org/understanding-migraine/treatment-of-cluster-headache/.
Accessed April 19, 2017.
Refer to: Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172 (Lilly
Bio-Medicines)
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SOURCE Eli Lilly and Company