INDIANAPOLIS, Sept. 8, 2017 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that treatment with
self-administered galcanezumab for up to 12 months demonstrated a
positive safety and tolerability profile in patients with migraine,
consistent with previous studies. Detailed results from a 12-month,
open-label Phase 3 study will be presented today at the 18th
Congress of the International Headache Society (IHC) in
Vancouver.
Over the 12-month treatment period, galcanezumab was also
associated with a statistically significant reduction in the number
of monthly migraine headache days with both doses (5.6 days for 120
mg and 6.5 days for 240 mg, p<0.001 for both dosing groups).
Notably, there was no clinically meaningful difference in the rate
of adverse events between galcanezumab 120 mg and 240 mg dosing
groups.
"These long-term results are significant for the millions of
Americans with migraine. They reinforce the efficacy and safety
profile of galcanezumab while supporting its potential use as a
self-administered, monthly injection," said Christi Shaw, president of Lilly Bio-Medicines.
"After more than two decades of research, Lilly is excited to
submit galcanezumab to the FDA as a new potential treatment option
that can provide more migraine-free days for people suffering with
migraine."
Lilly plans to submit a Biologics License Application (BLA) to
the U.S. Food and Drug Administration (FDA) for
galcanezumab in the second half of 2017, followed by submissions to
other regulatory agencies around the world.
Study Results
Patients were randomized to treatment
with galcanezumab 120 mg or galcanezumab 240 mg once-monthly for 12
months. The initial dose of galcanezumab was administered by a
healthcare provider, with subsequent doses self-administered by the
patient via prefilled syringe or auto-injector pen.
The most commonly reported adverse events (≥10%) in both dosing
groups included injection site pain, nasopharyngitis and upper
respiratory tract infection. Serious adverse events were reported
by three patients in the 120 mg dosing group and seven patients in
the 240 mg group.
In this study, 4.8 percent of patients discontinued treatment
due to adverse events. The incidence of both treatment-emergent
adverse events and adverse events leading to study discontinuation
were not statistically significantly different between the two
dosing groups.
Lilly will submit these findings for publication in a
peer-reviewed journal in the coming year.
Study Design
This 12-month, randomized, open-label
study evaluated the safety and effectiveness of two doses of
galcanezumab administered subcutaneously (120 mg or 240 mg
once-monthly, following a 240 mg starting dose) in 270 patients
with episodic and chronic migraine. Patients that participated in
the trial had an average of 10.6 migraine headache days per month
at baseline. The primary endpoints included the percentage of
patients who discontinued treatment with galcanezumab and
additional safety measures.
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.3,4 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
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 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 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, 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 September 7, 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 September 7, 2017.
4 Migraine facts. Migraine Research Foundation website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed September 7, 2017.
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)
|
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SOURCE Eli Lilly and Company