INDIANAPOLIS, June 17, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) announced today that its investigational
medicine for prevention of migraine (LY2951742, a CGRP neutralizing
antibody) met the primary endpoint in a Phase 2b study in episodic
migraine.
The randomized, double-blind, placebo-controlled study evaluated
the efficacy and safety of four different doses of LY2951742 given
in a once-monthly, subcutaneous injection in more than 400 patients
with episodic migraine (people who experience between four and 14
migraine headache days per month).
The primary objective was to assess whether at least one dose of
LY2951742 was superior to placebo in the prevention of migraine
headache. LY2951742 demonstrated a statistically significant
reduction in migraine headache days and a safety and tolerability
profile confirming the previous results seen in a Phase 2a
study.
Lilly will present data from this trial in a late-breaking
session at the 57th Annual American Headache Society
meeting on June 20 in Washington D.C., and will submit data from the
study for additional disclosure at scientific meetings and in
peer-reviewed journals.
"We're encouraged by the results from this positive Phase 2b
study that confirms the safety and efficacy profile of LY2951742,"
said David Ricks, Lilly senior vice
president, and president of Lilly Bio-Medicines. "These results
reinforce our confidence in the potential of this medicine to be a
significant option for the preventive treatment of debilitating
headache disorders like migraine and cluster headache."
In addition to the migraine program, Lilly has initiated two
Phase 3 trials with LY2951742 in patients suffering from cluster
headache. Based on the unmet medical need and significance of this
disorder for patients, Lilly has been granted Fast Track
Designation from the U.S. Food and Drug Administration (FDA) for
cluster headache.
About LY2951742
LY2951742 is a once-monthly
subcutaneously injected calcitonin gene-related peptide (CGRP)
antibody currently being studied as a potential treatment for the
prevention of chronic and episodic migraine and cluster headache.
Lilly's CGRP antibody is a biologic entity that binds and inhibits
the activity of CGRP, a sensory neuropeptide thought to be
associated with vasodilation, pro-inflammatory effects and pain
signaling, all thought to be implicated in the pathophysiology of
migraine and cluster headache.
About Migraine
Migraine is a neurological disorder
characterized by recurrent episodes of severe headache, often
accompanied by a variety of other symptoms including nausea,
vomiting, sensitivity to light and sound and changes in
vision. Thirty-six million Americans, about 12 percent of the
population, suffer from migraines at least periodically. It is
estimated that 38 percent of migraine sufferers -- people with
between four and 30 headache days per month -- could benefit from
preventive treatment, yet only 13 percent report using a daily
preventive migraine medication, resulting in a significant unmet
medical need for patients. The World Health Organization places
migraine as one of the 20 most disabling illnesses. People with
migraine are more likely to have depression, anxiety, sleep
disorders, other pain conditions and fatigue. It is estimated that
each year, lost work time and diminished productivity from
migraines cost American employers $225.8
billion.1,2,3 There currently is no cure for
migraine.
About Cluster Headache
Cluster headache is an
excruciatingly painful condition characterized by recurrent, severe
headaches (called "attacks") on one side of the head, usually
behind or around the eye. These attacks can occur daily to multiple
times daily for weeks or longer, followed by periods of times in
which no attacks occur. Cluster headache is relatively uncommon,
estimated to affect fewer than 200,000 people in the United States. There are no approved
medicines for the prevention of cluster headache in the United States.
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
newsroom.lilly.com/social-channels. P-LLY
This press release contains certain forward-looking statements
about LY2951742, a calcitonin gene-related peptide (CGRP) antibody
currently being studied as a potential treatment for the prevention
of migraine headaches and cluster headaches, and reflects Lilly's
current beliefs. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of
development and commercialization. There is no guarantee that
future study results and patient experience will be consistent with
the study findings to date, that LY2951742 will receive regulatory
approval or, if approved, would be commercially successful. For
further discussion of these and other risks and uncertainties, see
Lilly's filings with the United States Securities and Exchange
Commission. Lilly undertakes no duty to update forward-looking
statements.
1. Stewart WF, Ricci JA, Chee E, et al. Lost productive work
time costs from health conditions in the
United States: results from the American Productivity Audit.
J Occup Environ Med. 2003 Dec;45(12):1234â€"46.
2. Hu XH, Markson LE, Lipton RB, et al. Burden of migraine in
the United States: disability and
economic costs. Arch Intern Med. 1999 Apr 26;159(8):813â€"8.
3. Burton WN, Landy SH, Downs KE, et al. The impact of migraine and
the effect of migraine treatment on workplace productivity in
the United States and suggestions
for future research. Mayo Clin Proc.
2009 May;84(5):436â€"45.
Refer to: Scott
MacGregor; jsmacgregor@lilly.com;
+1-317-440-4699
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