THOUSAND OAKS, Calif.,
April 17, 2018 /PRNewswire/
-- Amgen (NASDAQ: AMGN) today announced full results from the
Phase 3b LIBERTY trial of Aimovig™
(erenumab) in episodic migraine patients who had previously failed
two to four preventive treatments, due to lack of efficacy or to
intolerable side effects.1 The data, which will be
presented at the 70th Annual Meeting of the American
Academy of Neurology (AAN) in Los
Angeles, show the potential of Aimovig as an effective
preventive treatment option for these patients, who have tried
several treatment options without gaining relief. Aimovig is the
only investigational fully human monoclonal antibody under
regulatory review that was designed to selectively block the
calcitonin gene-related peptide (CGRP) receptor, which plays a
critical role in migraine activation. LIBERTY is the first study to
investigate a treatment targeting the CGRP pathway specifically in
this challenging patient population.
In LIBERTY, 246 patients who had experienced two to four
previous preventive treatment failures were randomized to receive
monthly subcutaneous injections of either Aimovig 140 mg or placebo
for 12 weeks. Patients taking Aimovig had nearly three-fold higher
odds of having their migraine days cut by at least 50 percent, with
more than twice as many patients taking Aimovig achieving this
reduction compared to placebo (weeks 9-12: 30.3 percent with
Aimovig, 13.7 percent with placebo, p<0.002, odds ratio
2.73).
"We are encouraged by these new findings, which add to the
growing body of clinical evidence supporting potential use of
Aimovig across a broad spectrum of patients with migraine, all of
whom live with what is considered one of the most disabling
diseases," said Sean E. Harper, M.D., executive vice president
of Research and Development at Amgen. "These data support the
overall efficacy and safety profile we have seen consistently
during extensive clinical study of Aimovig, and speak to its
potential to help fill treatment gaps in more difficult patient
populations whose migraine has not been adequately managed with
current therapies."
In the study, patients taking Aimovig also had statistically
significant and clinically meaningful improvements from baseline
compared to placebo across all secondary endpoints:
- Reduction in monthly migraine days
- Decrease in monthly acute migraine-specific drug use
- 75 percent or greater reduction in monthly migraine days
- 100 percent reduction in monthly migraine days
- Improved physical functioning and ability to complete everyday
activities as measured by the Migraine Physical Function Impact
Diary (MPFID)
Over 97 percent of Aimovig patients completed the double-blind
phase of the LIBERTY study. There were no adverse events leading to
discontinuation of treatment in the Aimovig group, while 0.8
percent of those in the placebo group experienced adverse events
leading to discontinuation of treatment.
"The LIBERTY study distinctively demonstrates the ability of an
anti-CGRP receptor antibody to significantly
reduce migraine frequency and its associated burden
in patients who could not find the relief they need from
currently available
preventive treatment options," said professor Uwe
Reuter, managing medical director at Charité
Universitätsmedizin in Berlin.
"These compelling data offer new hope of fewer migraine days to
those people with migraine who may have cycled through current
standard of care unsuccessfully for years due to lack of efficacy
and tolerability."
The long-term open label extension phase of the study is
ongoing. LIBERTY contributes to an extensive body of evidence,
across the spectrum of migraine, in support of the efficacy, safety
and tolerability profile of Aimovig. Aimovig has been studied in
four placebo-controlled Phase 2 and Phase 3 clinical studies
involving more than 3,000 patients and continues to be studied in
an ongoing open-label extension for up to five years in
duration.
The U.S. Food and Drug Administration (FDA) has set a
Prescription Drug User Fee Act (PDUFA) target action date of
May 17, 2018, for Aimovig and the
European Medicines Agency has validated the Marketing Authorization
Application (MAA) for Aimovig. If approved, it will be administered
once-monthly using a self-injection device. If approved, Amgen and
Novartis will co-commercialize Aimovig in the U.S. Amgen has
exclusive commercialization rights to the drug in Japan, and Novartis has exclusive rights to
commercialize in rest of world.
About LIBERTY
LIBERTY (NCT03096834) is a Phase
3b, multicenter, randomized 12-week,
double-blind, placebo-controlled study evaluating the safety and
efficacy of Aimovig in patients with episodic migraine (defined in
the trial as four to 14 migraine days per month at baseline) who
have failed up to four prior preventive treatments for migraine. In
the study, 246 participants with episodic migraine who had two to
four previous treatment failures were randomized to receive Aimovig
140 mg or placebo during the 12-week double-blind treatment phase.
The primary endpoint was the percentage of patients with at least a
50 percent reduction of monthly migraine days from baseline over
the last four weeks of the double-blind treatment phase of the
study (weeks 9-12).1 The study includes an ongoing
52-week open-label extension study.
Secondary endpoints assessed during the same time period
included: change from baseline in monthly migraine days, change
from baseline in the number of monthly acute migraine-specific
medication treatment days and change from baseline in the Migraine
Physical Function Impact Diary (MPFID) physical impairment and
impact on everyday activities domain scores. The MPFID is a scale
developed to measure these two domains. The scale has been
validated in line with FDA Patient Reported Outcomes
Guidance.2 Percentages of patients with a 75 percent
response rate and 100 percent response rate to Aimovig were also
assessed as secondary endpoints.
About Aimovig™ (erenumab)
Aimovig is the only
investigational treatment under regulatory review that was
specifically designed to prevent migraine by blocking the CGRP
receptor, which is associated with migraine activation. Aimovig has
been studied in several large global, randomized, double-blind,
placebo-controlled studies to assess its safety and efficacy in
migraine prevention. More than 3,000 patients have participated in
the Aimovig clinical program across four placebo-controlled Phase 2
and Phase 3 clinical studies and their open-label extensions.
About Migraine
People with frequent migraine may lose
more than half their life to migraine days. Migraine robs
individuals of time with their families, productivity at home and
at work, and their livelihoods.3 People with migraine
endure debilitating pain and physical impairment, and live in
constant dread of the next attack – all of which is compounded by a
widespread misperception of the disease.3 The World
Health Organization ranks migraine among the top 10 causes of years
lived with disability worldwide.4 For the approximately
8 million Americans whose migraine frequency or severity impacts
daily activities, preventive medications may be an
option.3,5,6 Migraine is associated with personal and
societal burdens of pain, disability and financial cost, and it
remains under-recognized and under-treated.3
About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a
global collaboration with Novartis to develop and commercialize
pioneering treatments in the field of migraine and Alzheimer's
disease. The collaboration focuses on investigational Amgen drugs
in the migraine field, including Aimovig (Biologics License
Application submitted to FDA in May
2017) and AMG 301 (currently in Phase 2 development). In
April 2017, the collaboration was
expanded to include co-commercialization of Aimovig in the U.S. For
the migraine programs, Amgen retains exclusive commercialization
rights in the U.S. (other than for Aimovig as described above) and
Japan, and Novartis has exclusive
commercialization rights in Europe, Canada and rest of world. Also, the companies
are collaborating in the development and commercialization of a
beta-secretase 1 (BACE) inhibitor program in Alzheimer's disease.
The oral therapy CNP520 (currently in Phase 3 for Alzheimer's
disease) is the lead molecule and further compounds from both
companies' pre-clinical BACE inhibitor programs may be considered
as 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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contains forward-looking statements that are based on the current
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statements of historical fact, are statements that could be deemed
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Commission reports filed by Amgen, including our most recent annual
report on Form 10-K and any subsequent periodic reports on Form
10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen
is providing this information as of the date of this news release
and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
identification of new product candidates or development of new
indications for existing products cannot be guaranteed and movement
from concept to product is uncertain; consequently, there can be no
guarantee that any particular product candidate or development of a
new indication for an existing product will be successful and
become a commercial product. Further, preclinical results do not
guarantee safe and effective performance of product candidates in
humans. The complexity of the human body cannot be perfectly, or
sometimes, even adequately modeled by computer or cell culture
systems or animal models. The length of time that it takes for us
to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar
variability in the future. Even when clinical trials are
successful, regulatory authorities may question the sufficiency for
approval of the trial endpoints we have selected. We develop
product candidates internally and through licensing collaborations,
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we or others could identify safety, side effects or manufacturing
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for a portion of our manufacturing activities, and limits on supply
may constrain sales of certain of our current products and product
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implicate an entire class of products could have a material adverse
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The scientific information discussed in this news release
related to our product candidates is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, and no conclusions can or should be drawn regarding
the safety or effectiveness of the product candidates.
*The trade name Aimovig™ is provisionally approved for use by
the U.S. Food and Drug Administration.
CONTACT: Amgen, Thousand
Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
(media)
Arvind Sood, 805-447-1060
(investors)
References
1 Reuter, U et al. Efficacy and
safety of erenumab in episodic migraine patients with 2–4 prior
preventive treatment failures: Results from the Phase 3b LIBERTY study. Emerging science abstract
presented at AAN, 24 April 2018,
Los Angeles.
2 Kawata AK et al. Psychometric Evaluation of a Novel
Instrument Assessing the Impact of Migraine on Physical
Functioning: The Migraine Physical Function Impact Diary. Headache.
2017; 57(9) 1385-1398.
3 Lipton RB, et al. Migraine prevalence, disease burden,
and the need for preventative therapy. Neurology. 2007;
68(5):343-9.
4 GBD 2016 Disease and Injury Incidence and Prevalence
Collaborators. Global, regional, and national incidence,
prevalence, and years lived with disability for 328 diseases and
injuries for 195 countries, 1990–2016: a systematic analysis for
the Global Burden of Disease Study 2016. Lancet.
2017;388:1545-1602.
5 Buse DC, et al. Chronic migraine prevalence,
disability, and sociodemographic factors: results from the American
Migraine Prevalence and Prevention Study. Headache. 2012; 52(10):
1456-70.
6 U.S. Census Bureau Age and Sex 2012-2016 Estimates.
Available:
https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?pid=ACS_16_5YR_S0101&prodType%20=table.
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