INDIANAPOLIS,
Dec. 11, 2017 /PRNewswire/ -- Eli
Lilly and Company (NYSE: LLY) announced today that the U.S. Food
and Drug Administration (FDA) has accepted a Biologics License
Application (BLA) to review galcanezumab for the prevention of
migraine in adults. Galcanezumab has been submitted for use as a
once-monthly, self-administered injection via auto-injector pen or
prefilled syringe.
Lilly announced the submission of the BLA on its
third-quarter earnings call in October
2017.
The application includes positive data from three Phase 3
studies (EVOLVE-1, EVOLVE-2 and REGAIN), which evaluated 2,901
patients. In these studies, patients treated with
galcanezumab experienced a statistically significantly
greater decrease in the average number of monthly migraine headache
days compared to placebo. The most
commonly-reported adverse events were injection site reactions,
including pain.
"Migraine is more than a headache. It is a debilitating
disease affecting one in eight Americans and may cause days of lost
productivity each month," said Christi Shaw, president of Lilly
Bio-Medicines. "We have worked for more than 25 years
to develop innovative migraine therapies, and we are truly pleased
to be one step closer to potentially providing a new
self-administered and effective preventive treatment option that
may help people experience fewer migraine days."
Galcanezumab represents the first of three
investigational, non-opioid treatments in development as part of
Lilly's overall pain portfolio. The portfolio
also includes lasmiditan for the acute treatment of migraine
and tanezumab, developed in partnership with Pfizer, for the
treatment of osteoarthritis, chronic low back pain and cancer
pain.
About Galcanezumab
Galcanezumab is
a monoclonal antibody specifically designed to bind to and inhibit
the activity of calcitonin gene-related peptide (CGRP), which is
believed to play a role in migraine and cluster headache.
Galcanezumab is an investigational once-monthly, self-administered
injection under evaluation for the prevention of migraine and
cluster headache.
About Migraine
Migraine is a
disabling neurological disease characterized by recurrent episodes
of severe headache accompanied by other symptoms
including nausea, vomiting, sensitivity to light and sound, and
changes in vision.1,2 More than 36 million
Americans have migraine, with three times more women affected by
migraine compared to men.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
U.S., yet it remains under-recognized and
under-treated.4,5
About Lilly in Migraine
For over 25
years, Lilly has been committed to helping people suffering from
migraine, investigating more than a dozen different compounds for
the treatment of migraine and disabling headache disorders.
These research programs have accelerated understanding of
this disease and advanced the development of Lilly's comprehensive
late-stage development programs studying galcanezumab for
prevention of migraine and cluster headache, and lasmiditan for the
acute treatment of migraine. Our goal is to make life
better for people with migraine by offering comprehensive solutions
to prevent or stop this disabling disease. The combined clinical,
academic and professional experience of our experts helps us to
build our research portfolio, identify challenges for healthcare
providers and pinpoint the needs of people living with migraine and
cluster headache.
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 preventive treatment
for patients with migraine, 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 receive 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.
1 Headache disorders. World Health
Organization website.
http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed
December 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/.
Last accessed December 5,
2017.
4 Migraine
facts. Migraine Research Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed December 5,
2017.
5
Blumenfeld AM, Bloudek LM, Becker WJ, et al. Patterns of use
and reasons for discontinuation of prophylactic medications for
episodic migraine and chronic migraine: results from
the Second International Burden of Migraine Study (IBSM-II).
Headache. 2013;53(4):644-655.
Refer
to:
|
Jen Dial;
dial_jennifer_kay@lilly.com; 317-220-1172(Lilly
Bio-Medicines)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; 317-655-6874 (Investor
Relations)
|
SOURCE Eli Lilly and Company