THOUSAND OAKS, Calif.,
Oct. 3, 2020 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) today announced that results reinforcing the
long-term safety and efficacy profile of Aimovig®
(erenumab-aooe) in patients with episodic migraine (EM) are being
presented at the Migraine Trust Virtual Symposium. Results from the
five-year, open-label treatment period of a Phase 2 study in
episodic migraine prevention (NCT01952574) showed Aimovig helped
patients achieve sustained reductions in monthly migraine days
(MMD) and in use of acute migraine-specific medication (AMSM), such
as triptans. Additionally, the safety profile was consistent with
what was observed in the double-blind treatment phase of the study,
with no increases in adverse event rates over five years of
exposure.1
"These important data highlight the sustained efficacy, safety
and tolerability profile of Aimovig, and provide crucial
information for patients and doctors managing migraine," said Dr.
Messoud Ashina, professor of neurology in the Faculty of Health and
Medical Sciences at the University of
Copenhagen. "The study reinforces the potential of Aimovig
to reduce monthly migraine days over the long term for people
living with this debilitating, yet underdiagnosed disease. For my
patients, more migraine-free days means they're able to get back to
the things that are important to them, like spending more time with
family and friends, and being able to go to
work."1-4
The five-year, open-label treatment phase enrolled 383 patients
with episodic migraine who completed a 12-week double-blind,
placebo-controlled treatment period (DBTP).1 Among the
216 patients who completed the open-label treatment phase, there
was an average MMD reduction of 5.3 days from the DBTP baseline of
8.7 days.1 By the end of the study, patients who used
AMSM to treat their migraine headaches experienced an average
reduction in AMSM use of 4.4 days from the DBTP baseline of 6.2
days.1 The most common side effects were
nasopharyngitis, upper respiratory tract infection, and
influenza.1
"Aimovig continues to have the longest safety and efficacy trial
data among treatments for migraine in the calcitonin gene-related
peptide class of medications," said Darryl
Sleep, M.D., senior vice president, Global Medical, and
chief medical officer at Amgen. "Many people with this debilitating
neurological disease live in dread of the next attack.3
As the first FDA-approved treatment and most prescribed preventive
therapy in this class, Aimovig continues to be at the forefront of
preventive migraine treatment and clinical research.5,6
These long-term results further demonstrate the potential of
Aimovig to help the millions of patients who may be candidates for
preventive treatment."1,2,7,8
Additional studies highlighting Aimovig will be presented at the
Migraine Trust Virtual Symposium, including interim results of the
LIBERTY open-label extension study, as well as efficacy and safety
results of Aimovig in the EMPOwER study. These studies reinforce
the safety and efficacy profile of Aimovig for patients of various
backgrounds across the episodic migraine spectrum.
- Interim two-year results of the open-label extension study of
the LIBERTY study (NCT03096834) showed sustained efficacy and no
increases in adverse events rates for patients with episodic
migraine taking Aimovig who failed 2-4 prior preventive
treatments.9
- Results of the Phase 3 EMPOwER study (NCT03333109) highlighted
the efficacy and safety of Aimovig in adult patients with episodic
migraine from Asia, the
Middle East and Latin America.10,11
About the Open Label Extension Phase of the Phase 2
Study in Episodic Migraine Prevention (NCT01952574)
After a
12-week randomized, double-blind, placebo-controlled period, 383
eligible adult patients with episodic migraine (defined in the
trial as 4 to 14 migraine days and less than 15 headache days per
month at baseline) were enrolled in the open-label treatment
phase.1,12 All patients initially
received 70 mg Aimovig monthly, with 250 patients increasing their
dosage to 140 mg monthly after a protocol amendment to assess
long-term safety of the higher dose.1,12,13 Safety and
tolerability were assessed by monitoring adverse events,
electrocardiograms, laboratory assessments, and vital
signs.1
No new safety signals or increases in adverse event rates were
observed over five years of exposure with Aimovig as compared to
the DBTP, in which the safety and tolerability profiles of Aimovig
were in line with other clinical trial data.1 The most
common side effects were nasopharyngitis, upper respiratory
tract infection, and influenza.
About Aimovig®
(erenumab-aooe)
Aimovig, co-marketed in the U.S. by
Amgen and Novartis, is the first and only FDA and EMA-approved
migraine preventive treatment that targets the calcitonin
gene-related peptide (CGRP) receptor, which is associated with
migraine.5,14 Aimovig has been studied in several large,
global, randomized, double-blind, placebo-controlled studies to
assess its efficacy and safety in migraine
prevention.15,16 Aimovig is self-administered once
monthly via the easy-to-use SureClick® autoinjector,
without a required loading dose.16 More than 3,000
patients participated in registrational trials of Aimovig across
four placebo-controlled Phase 2 and Phase 3 clinical studies and
their open-label extensions.1,9,10,15,16
Aimovig is also being evaluated through CATALYST, a
comprehensive evidence generation program initiated by Amgen and
Novartis that includes over 7,500 patients across 14 ongoing
clinical trials and a robust assessment of real-world evidence.
Spanning over 39 countries globally, CATALYST clinical trials will
explore the role of Aimovig in comparative studies, assessing
impact on novel migraine outcomes, understanding predictive
biomarkers and expanding Aimovig's use in additional study
populations. To date, more than 440,000 patients across 44
countries worldwide have been prescribed Aimovig for the preventive
treatment of migraine in adults.18
AIMOVIG INDICATION
Aimovig® (erenumab-aooe)
is indicated for the preventive treatment of migraine in
adults.
IMPORTANT SAFETY INFORMATION
Contraindication:
Aimovig® is contraindicated in patients with serious
hypersensitivity to erenumab-aooe or to any of the excipients.
Reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions,
including rash, angioedema, and anaphylaxis, have been reported
with Aimovig® in post marketing experience. Most
reactions were not serious and occurred within hours of
administration, although some occurred more than one week after
administration. If a serious or severe reaction occurs, discontinue
Aimovig® and initiate appropriate therapy.
Constipation with Serious Complications: Constipation
with serious complications has been reported following the use of
Aimovig® in the postmarketing setting. There were cases
that required hospitalization, including cases where surgery was
necessary. The onset of constipation was reported after the first
dose in a majority of these cases, but patients also reported later
on in treatment. Aimovig® was discontinued in most
reported cases. Constipation was one of the most common (up to 3%)
adverse reactions reported in clinical studies.
Monitor patients treated with Aimovig® for severe
constipation and manage as clinically appropriate. Concurrent use
of medications associated with decreased gastrointestinal motility
may increase the risk for more severe constipation and the
potential for constipation-related complications.
Hypertension: Development of hypertension and
worsening of pre-existing hypertension have been reported following
the use of Aimovig® in the postmarketing setting. Many
of the patients had pre-existing hypertension or risk factors for
hypertension. There were cases requiring pharmacological treatment
and, in some cases, hospitalization. Hypertension may occur at any
time during treatment but was most frequently reported within seven
days of dose administration. In the majority of the cases, the
onset or worsening of hypertension was reported after the first
dose. Aimovig® was discontinued in many of the reported
cases.
Monitor patients treated with Aimovig® for new-onset
hypertension, or worsening of pre-existing hypertension, and
consider whether discontinuation of Aimovig® is
warranted if evaluation fails to establish an alternative
etiology.
Adverse Reactions: 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 see Aimovig® full Prescribing
Information.
About Migraine
People with frequent migraine attacks
may lose more than half their life to migraine.12 One
attack could last up to three days.12 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.3,19 The 2017 Global Burden
of Disease Study ranks migraine among the top 10 causes of years
lived with disability worldwide.20 Migraine is
associated with personal and societal burdens of pain, disability,
and financial cost, and it remains under-recognized and
under-treated.2,4
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. 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).5 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. 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 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.
Amgen Forward-Looking Statements
This news release
contains forward-looking statements that are based on the current
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forward-looking statements, including any statements on the
outcome, benefits and synergies of collaborations, or potential
collaborations, with any other company, including BeiGene, Ltd. or
any collaboration or potential collaboration in pursuit of
therapeutic antibodies against COVID-19 (including statements
regarding such collaboration's, or our own, ability to discover and
develop fully-human neutralizing antibodies targeting SARS-CoV-2 or
antibodies against targets other than the SARS-CoV-2 receptor
binding domain, and/or to produce any such antibodies to
potentially prevent or treat COVID-19), or the Otezla®
(apremilast) acquisition (including anticipated Otezla sales growth
and the timing of non-GAAP EPS accretion), as well as estimates of
revenues, operating margins, capital expenditures, cash, other
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outcomes, effects of pandemics or other widespread health problems
such as the ongoing COVID-19 pandemic on our business, outcomes,
progress, or effects relating to studies of Otezla as a potential
treatment for COVID-19, and other such estimates and
results. Forward-looking statements involve significant risks
and uncertainties, including those discussed below and more fully
described in the Securities and Exchange 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
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events or otherwise.
No forward-looking statement can be guaranteed and actual
results may differ materially from those we project. Discovery or
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Our results may be affected by our ability to successfully
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CONTACT: Amgen, Thousand
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