THOUSAND OAKS,
Calif., June 28,
2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced that the results of two open-label extension (OLE)
studies of Aimovig™ (erenumab-aooe) in patients with chronic and
episodic migraine, respectively, will be presented at the
60th Annual Scientific Meeting of the American Headache
Society (AHS) in San
Francisco. Results from a one-year study in chronic migraine
patients reinforced the established safety and efficacy profile of
Aimovig in long-term use. In addition, a three-year interim
analysis from an ongoing five-year study of episodic migraine
patients, the longest running study of a calcitonin gene-related
peptide (CGRP) therapy, reinforced the long-term safety and
tolerability of Aimovig. Aimovig is the first and only FDA-approved
therapy targeting the CGRP pathway.
In the one-year OLE study in chronic migraine, the primary
and secondary outcome measures of the study were long-term safety
and efficacy, respectively.1 The safety results after
one year were consistent with the established safety profile of
Aimovig in previous studies. The most frequent adverse events (AEs)
greater than 2.0 per 100-subject-years were viral upper respiratory
tract infection, upper respiratory tract infection, sinusitis,
arthralgia and migraine. In the double-blind treatment phase, no
differences were observed in the safety events between Aimovig and
placebo.
The efficacy data showed sustained benefits up to one
year. Patients taking Aimovig 140 mg and 70 mg (based on last dose
received) achieved reductions of average monthly migraine days of
10.5 and 8.5 days, respectively, compared to a baseline of 18.1 (at
the time of enrollment into the placebo-controlled study, after one
year of treatment). Patients treated with Aimovig experienced
reductions in monthly migraine days of:
- 50 percent or more: 67 percent on 140 mg and 53 percent
on 70 mg
- 75 percent or more: 42 percent on 140 mg and 27 percent
on 70 mg
- 100 percent reduction: 13 percent on 140 mg and 6 percent
on 70 mg
"These data showing sustained efficacy and consistent
safety and tolerability of Aimovig over an extended period of time
are important for migraine patients and their clinicians to know,"
said Stewart J. Tepper, M.D.,
professor of neurology at the Geisel School of Medicine at
Dartmouth Medical School. "Collectively these data reinforce the
safety and tolerability of Aimovig, and having a treatment
specifically designed for migraine has the potential to truly
improve the lives of those living with this neurological
disease."
The five-year OLE study in episodic migraine is assessing
the long-term safety and tolerability of
Aimovig.2 The results at the three-year
interim data analysis showed Aimovig had a safety profile
consistent with the spectrum and rate of AEs seen in shorter-term
placebo-controlled studies, no new AEs and no new causally-related
serious AEs. The most frequent AEs were viral upper respiratory
tract infection, upper respiratory tract infection, sinusitis,
influenza and back pain. There was no increase in cardiovascular
events over time and no meaningful changes in systolic/diastolic
blood pressure or heart rate up to the ~3.2-year
follow-up.2
"On the heels of the recent FDA approval of Aimovig for
the preventive treatment of migraine in adults, the results of
these open-label extension studies are encouraging as they
contribute to a growing and extensive body of evidence that support
the use of Aimovig across the spectrum of migraine," said
Sean E. Harper, M.D., executive vice
president of Research and Development at Amgen. "These data
underscore our commitment to building robust clinical programs in
both chronic and episodic migraine that further demonstrate the
clinical utility of Aimovig. Our underlying goal is to improve the
lives of people living with this debilitating disease."
Additional data in patients with chronic migraine are
being presented at the AHS meeting, including long-term efficacy of
Aimovig in patients with overuse of acute medication, long-term
efficacy of Aimovig in patients who failed prior prophylactic
treatment, and efficacy of Aimovig at varying dosage strengths in
the Phase 3 STRIVE study.
About the Open-Label Extension Study in Chronic
Migraine
After the 12-week randomized,
double-blind placebo-controlled parent study, eligible patients
could enroll in the OLE study. 451 patients completed the study
receiving either Aimovig 70 mg, 140 mg or changing from 70 mg to
140 mg during the course of the study.1 Of the 609
patients who enrolled in the study, 199 increased their dose from
70 mg to 140 mg by week 28.1
The primary outcome measure of the study was long-term
safety. The secondary outcome measure was efficacy, as determined
by four measures: change from baseline to week 52 in monthly
migraine days (MMD), monthly acute migraine-specific medication
days, monthly cumulative hours of headache, and proportion of
patients achieving at least a 50 percent reduction in
MMD.
About the Open-Label Extension Study in Episodic
Migraine
Following a 12-week randomized,
placebo-controlled phase of a (Phase 2) study of Aimovig in adults
with episodic migraine, patients could continue into the open-label
extension phase, initially receiving 70 mg Aimovig monthly. A
protocol amendment increased the dosage to 140 mg monthly to assess
long-term safety of the higher dose. Safety and tolerability were
assessed by monitoring AEs, electrocardiograms, laboratory
assessments and vital signs. Of the 383 patients who enrolled in
the open-label extension, 235 patients (61.3 percent) remained in
the OLE study at the data cutoff point for this interim analysis,
all having received Aimovig for at least three years. The study is
continuing for up to five years of treatment.
Safety and efficacy data after four and five years of
treatment will be reported in the future.
About Aimovig™ (erenumab-aooe)
Aimovig is the only FDA-approved treatment specifically
developed to prevent migraine by blocking the CGRP-R, which is
associated with migraine. Aimovig has been studied in several large
global, randomized, double-blind, placebo-controlled studies to
assess its efficacy and safety 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.
U.S. Aimovig Indication
Aimovig is indicated for the preventive treatment of
migraine in adults.
U.S. Aimovig Important Safety
Information
- The most common adverse reactions in clinical studies (≥
3% of Aimovig™-treated patients and more often than placebo) were
injection site reactions and constipation.
Please
visit www.amgen.com or www.aimovig.com for
Full U.S. Prescribing Information.
About Migraine
People with frequent
migraine may lose more than half their life to migraine. They
endure debilitating pain, 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 2016
Global Burden of Disease Study ranks migraine among the top 10
causes of years lived with disability
worldwide.4 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 (approved by the FDA in May 2018 for the preventive treatment of migraine
in adults) 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. At the center of the Amgen and Novartis
neuroscience collaboration is the shared mission to fight migraine
and the stereotypes and misperceptions surrounding this
debilitating disease.
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 biologics manufacturing 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 the world's largest independent biotechnology company, 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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of the date of this news release and does not undertake any
obligation to update any forward-looking statements contained in
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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
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Such product candidates are not approved by the U.S. Food and
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CONTACT: Amgen, Thousand
Oaks
Kristen
Davis, 805-447-3008 (media)
Andrea Fassacesia, 805-905-2575
(media)
Arvind Sood,
805-447-1060 (investors)
References
1 Tepper
S, et al. Assessment of the Long-Term Safety and Efficacy of
Erenumab During Open-Label Treatment of Subjects With Chronic
Migraine. Data presented at 60th Annual Scientific Meeting of the
American Headache Society, San
Francisco, June
2018.
2 Ashina M, et
al. Long-term Safety and Tolerability of Erenumab: Three-plus Year
Results from an Ongoing Open-Label Extension Study in Episodic
Migraine. Data presented at 60th Annual Scientific
Meeting of the American Headache Society, San Francisco, June
2018.
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.
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