THOUSAND OAKS, Calif.,
Sept. 15, 2016 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced detailed global Phase 2 results
showing erenumab demonstrated a statistically significant reduction
in monthly migraine days compared with placebo in patients with
chronic migraine. The data will be presented in posters #P057 and
#P058 at the 5th European Headache and Migraine Trust
International Congress (EHMTIC) in Glasgow, Scotland.
"Chronic migraine patients lose more than half of their life to
migraines with 15 or more headache days a month, facing intolerable
pain and physical impairment," said Stewart
Tepper, M.D., professor of neurology at the Geisel School of
Medicine at Dartmouth. "As a
neurologist, these findings are exciting because they demonstrate
that erenumab could serve as an important new therapy option for
reducing the burden of this often-disabling disease."
The study included 667 patients (mean age 42.1, 79.0 percent
female) who were randomized to receive either subcutaneous placebo
(n=286) or subcutaneous erenumab 70 mg (n=191) or 140 mg (n=190)
once a month. Patients had a mean baseline of 18.0 migraine days
per month and a mean baseline of 21.1 headache days per month.
Patients randomized to both erenumab dose groups experienced a
statistically significant 6.6-day reduction from baseline in mean
monthly migraine days compared with 4.2 days observed in the
placebo group (p<0.001). All endpoint assessments
compared the last four weeks of the 12-week treatment phase to
baseline.
A reduction of 50 percent or more in number of monthly migraine
days was observed in 40 percent and 41 percent (70 mg and 140 mg
doses, respectively) of individuals in the erenumab groups at week
12, representing a significantly higher likelihood of response
compared to 24 percent of those receiving placebo (both
p<0.001). Reductions in monthly acute migraine-specific
medication days were 3.5 days and 4.1 days in the 70 mg and 140 mg
groups, respectively, representing significant improvements from
baseline compared to a 1.6-day reduction in those receiving placebo
(both doses p<0.001 versus baseline).
All groups showed numeric improvements in cumulative monthly
headache hours. Compared to a 55.2-hour reduction versus baseline
in the placebo group, reductions were 64.8 hours for 70 mg erenumab
and 74.5 hours for 140 mg erenumab.
In an analysis of exploratory endpoints, both doses of erenumab
were associated with significant improvements in health-related
quality of life, headache impact, disability, and level of pain
interference, compared to placebo.*
"Erenumab is specifically designed to prevent migraine by
blocking a receptor that is believed to have a critical role in
mediating the incapacitating pain of migraine," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "The results from
this global chronic migraine study are exciting because they
support the efficacy of erenumab for a patient population that has
had few therapeutic options. We look forward to advancing erenumab
to help provide a potential new treatment option for patients with
this debilitating disease."
The safety profile of erenumab was similar to placebo across
both treatment arms. No adverse event was reported in greater than
five percent of patients treated with erenumab. The most common
adverse events (in placebo, 70 mg erenumab, 140 mg erenumab groups,
respectively) were injection site pain (1.1 percent, 3.7 percent,
3.7 percent), upper respiratory tract infection (1.4 percent, 2.6
percent, 3.2 percent) and nausea (2.5 percent, 2.1 percent, 3.2
percent).
The World Health Organization ranks migraine as one of the most
debilitating of all illnesses.1,2 Chronic migraine is
the most disabling form of the disease, and is associated with
personal and societal burdens of pain, disability and financial
cost.3
Results from Phase 3 studies investigating erenumab in episodic
migraine are expected later this year. Erenumab is being
co-developed by Amgen and Novartis. As part of the collaboration,
Amgen retains commercialization rights in the U.S., Canada and Japan, and Novartis holds rights in
Europe and rest of world.
*Assessment tools for exploratory endpoints including the
Headache Impact Test (HIT-6™), the Migraine Disability Assessment
(MIDAS), the Migraine-Specific Quality-of-Life Questionnaire (MSQ),
and the Patient Reported Outcome Measurement Information System
(PROMIS®). Pain Interference Scale Short Form.
Exploratory endpoints were not adjusted for multiplicity.
About the 20120295 Study
The 20120295 study is a
global Phase 2, randomized, 12-week, double-blind,
placebo-controlled study evaluating the safety and efficacy of
erenumab in chronic migraine prevention. In the study, 667 patients
were randomized to receive once-monthly subcutaneous placebo or
erenumab (70 mg or 140 mg) in a 3:2:2 ratio, respectively. The
primary endpoint was change in monthly migraine days from baseline
to the last four weeks of the 12-week treatment phase in patients
with chronic migraine (the number of migraine days between weeks
nine and 12). Secondary study endpoints included reduction of at
least 50 percent from baseline in monthly migraine days, change
from baseline in monthly acute migraine-specific medication days
and change from baseline in cumulative monthly headache hours.
About Erenumab
Erenumab is a fully human monoclonal
antibody specifically designed for the prevention of migraine.
Erenumab targets and blocks the Calcitonin-Gene-Related-Peptide
(CGRP) receptor, thought to be pivotal in the genesis of migraine.
Erenumab is currently being studied in several large global,
randomized, double-blind, placebo-controlled trials to assess its
safety and efficacy in migraine prevention.
About Migraine
Migraine sufferers face intolerable
pain and physical impairment, which is frequently accompanied by
nausea, sensitivity to light, noise and other sensations and can
cause significant disruption of daily
activities.4 Migraine is associated with personal
and societal burdens of pain, disability, and financial cost, and
it remains under-recognized and under-treated, with more than 40
percent of people going
undiagnosed.5,6 In the U.S.,
approximately 38 million people suffer from migraine: about four
million with chronic migraine4 (experiencing at least 15
headache days per month, of which eight or more days have migraine
features) and over 30 million with episodic migraine (less than 15
migraine days a month).3
About Amgen and Novartis Neuroscience Collaboration
In
August 2015, Amgen entered into a
global collaboration with Novartis to jointly develop and
commercialize pioneering treatments in the field of migraine and
Alzheimer's disease (AD). The collaboration focuses on
investigational Amgen drugs in the migraine field, including
erenumab (currently in Phase 3 studies for episodic migraine as
well as open-label studies in episodic and chronic migraine) and
AMG 301 (currently in Phase 1). For the migraine program, Amgen
retains commercialization rights in the U.S., Canada and Japan, and Novartis has commercialization
rights in Europe and rest of
world. Also, the companies are partnering in the development and
commercialization of a beta-secretase 1 (BACE) inhibitor program in
AD. Novartis' oral therapy CNP520 (currently in a Phase 1/2a study
for AD) will be the lead molecule and further compounds from both
companies' pre-clinical BACE inhibitor programs may be considered
as novel follow-on molecules.
About Amgen
Amgen is committed to unlocking the
potential of biology for patients suffering from serious illnesses
by discovering, developing, manufacturing and delivering innovative
human therapeutics. This approach begins by using tools like
advanced human genetics to unravel the complexities of disease and
understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us
on www.twitter.com/amgen.
Forward-Looking Statements
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information as of the date of this news release and does not
undertake any obligation to update any forward-looking statements
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events or otherwise.
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results may differ materially from those we project.
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Further, preclinical results do not guarantee safe and effective
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human body cannot be perfectly, or sometimes, even adequately
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CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
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References
1 Vos T et al. Years lived with
disability (YLDs) for 1160 sequelae of 289 diseases and injuries
1990–2010: a systematic analysis for the Global Burden of Disease
Study 2010. The Lancet. 2012 Dec-2013
Jan;30(9859):2163-2196.
2 Steiner TJ et al. Migraine: the seventh disabler. J
Headache Pain. 2013;14(1):1.
3 Katsarava Z et al. Defining the difference between
episodic migraine and chronic migraine. Curr Pain Headache
Rep. 2012;16:86-92.
4 Migraine Research Foundation. Migraine Fact
Sheet. http://www.migraineresearchfoundation.org/fact-sheet.html.
Accessed September 9, 2016.
5 World Health Organization. Headache
disorders. http://www.who.int/mediacentre/factsheets/fs277/en/.
Updated April 2016. Accessed June 6, 2016.
6 Diamond S et al. Patterns of Diagnosis and Acute
and Preventive Treatment for Migraine in the United States: Results from the American
Migraine Prevalence and Prevention Study. Headache.
2007; 47(3): 355-63.
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