INDIANAPOLIS, May 12, 2017 /CNW/ -- Eli Lilly and
Company (NYSE: LLY) announced today that galcanezumab, an
investigational treatment for the prevention of episodic and
chronic migraine, met its primary endpoint in three Phase 3 studies
(EVOLVE-1, EVOLVE-2 and REGAIN) demonstrating statistically
significant reductions in the number of monthly migraine headache
days compared to placebo at both studied doses.
"The robust results from these three studies bring us one step
closer to helping people experience more migraine-free days, an
important treatment goal for those living with this serious
disease," said Christi Shaw,
president of Lilly Bio-Medicines. "The impact of migraine is
underestimated, with people who experience migraine attacks often
missing work, family activities or social engagements. For patients
with as few as one migraine headache day per week, this can mean
more than 50 days of lost productivity a year."
In these three studies, the most commonly-reported adverse
events were injection site reactions, including pain. The observed
safety and tolerability profile was consistent with findings from
previous studies of galcanezumab.
Based on these results, Lilly will submit a Biologics License
Application 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.
EVOLVE-1 and EVOLVE-2 Study Results
In both studies, over the six-month treatment period, patients
with episodic migraine treated with galcanezumab 120 mg and 240 mg
doses experienced a significantly greater decrease in the average
number of monthly migraine headache days compared to patients
treated with placebo.
- EVOLVE-1: Average reduction of 4.7 days for 120 mg and 4.6 days
for 240 mg compared to an average reduction of 2.8 days for
placebo, p<0.001 for both dosing groups.
- EVOLVE-2: Average reduction of 4.3 days for 120 mg and 4.2 days
for 240 mg compared to an average reduction of 2.3 days for
placebo, p<0.001 for both dosing groups.
Additionally, patients treated with galcanezumab experienced
statistically significant improvement compared to placebo on
several pre-specified secondary endpoints, including response rates
and measures of daily activities.
REGAIN Study Results
Over the three-month treatment
period, patients with chronic migraine treated with galcanezumab
120 mg and 240 mg doses experienced a significantly greater
decrease in the average number of monthly migraine headache days
compared to patients treated with placebo (average reduction of 4.8
days for 120 mg and 4.6 days for 240 mg compared to an average
reduction of 2.7 days for placebo, p<0.001 for both dosing
groups).
Additionally, patients treated with galcanezumab experienced
statistically significant improvement compared to placebo on
several pre-specified secondary endpoints, including response rates
and measures of daily activities.
"Lilly's commitment to the development of new treatments for
migraine has spanned more than 25 years, and in that time, we have
played an important role in advancing the understanding of this
serious disease," said Robert
Conley, M.D., Distinguished Lilly Scholar and Lilly global
development leader for migraine therapeutics. "The topline results
from these Phase 3 data are encouraging and reaffirm the potential
for galcanezumab to provide a new option for people living with
migraine."
Lilly will present detailed data from these studies at
scientific meetings later this year and submit the results to
peer-reviewed journals.
Lilly also is evaluating galcanezumab for the treatment of
cluster headache, with Phase 3 trial results expected in 2018.
Based on the unmet medical need and significance of this disease
for patients, Lilly has been granted Fast Track Designation from
the FDA.
About the EVOLVE-1 and EVOLVE-2 Studies
EVOLVE-1 and
EVOLVE-2 are six-month Phase 3, randomized, double-blind,
placebo-controlled global trials evaluating the safety and efficacy
of two doses of galcanezumab administered subcutaneously (120 mg or
240 mg once-monthly, following a 240 mg starting dose) compared
with placebo in patients with episodic migraine. To be eligible for
the trials, patients must have experienced between four and 14
migraine headache days per month. Patients that participated in
these trials had an average of 9.1 migraine headache days per month
at baseline. The primary endpoint was the mean change from baseline
in monthly migraine headache days over the six-month, double-blind
treatment phase.
About the REGAIN Study
REGAIN is a three-month Phase
3, randomized, double-blind, placebo-controlled global trial
evaluating the safety and efficacy of two doses of galcanezumab
administered subcutaneously (120 mg or 240 mg once-monthly,
following a 240 mg starting dose) compared with placebo in patients
with chronic migraine. To be eligible for the trial, patients must
have experienced at least 15 headache days per month, of which at
least eight met criteria for migraine. Patients that participated
in the trial had an average of 19.4 migraine headache days per
month at baseline. The primary endpoint was the mean change from
baseline in monthly migraine headache days over the three-month,
double-blind treatment phase. In REGAIN, galcanezumab was further
evaluated for an additional nine months of an open-label extension
phase following the three-month, double-blind treatment phase.
About Migraine
Migraine is a disabling 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.3 Of the approximately 40 percent of patients
suffering from migraine for whom prevention is appropriate, only 13
percent are currently receiving therapy.4,5,6 Results
from the Second International Burden of Migraine study show that
side effects of treatment play a role in this disconnect, with up
to 53 percent of respondents discontinuing migraine prevention
therapy because of side effects.7 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.3,7
About Lilly in Migraine
Lilly has been committed to
helping people suffering from migraine for over 25 years,
investigating more than a dozen different compounds for the
treatment of 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
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 patients 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 treatment for patients with
chronic and episodic 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, 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 May 11, 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 Migraine facts. Migraine Research Foundation
website.
http://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed May 11, 2017.
4 Lipton RB, Bigal ME, Diamond M, et al. Migraine
prevalence, disease burden and the need for preventive therapy.
Neurology. 2007;68(5):343-349.
5 Lafata, JE, Tuniceli O, Cerghet M, et al. The use of
migraine preventive medications among patients with and without
migraine headaches. Cephalagia. 2010;30(1):97-104.
6 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.
7 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; +1-317-220-1172 (media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (investors)
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