-
LIBERTY is the first migraine
prevention trial of its kind conducted specifically in patients who
have tried multiple therapies without success, and are in need of
additional treatment options
-
The trial met its primary
endpoint of percentage of patients on erenumab (AMG 334) achieving
at least a 50% reduction of migraine days versus placebo, and all
secondary endpoints
-
Statistically significant and
clinically meaningful results add to the consistent efficacy and
placebo-like safety profile of erenumab seen across the spectrum of
migraine, even in more difficult-to-treat patients
Basel, January 22, 2018
- Novartis today announced positive results
from the Phase IIIb LIBERTY study assessing the efficacy and safety
of erenumab (AMG 334) 140mg in patients with episodic migraine who
had experienced two to four previous preventive treatment failures,
due to lack of efficacy or intolerable side effects. The study met
its primary endpoint, with significantly more patients taking
erenumab experiencing at least a 50% reduction from baseline in
their monthly migraine days as compared to placebo. LIBERTY
also met all secondary endpoints including: reduction of monthly
migraine days, reduction in days needing acute (rescue) medication,
improvement in scores on the Migraine Physical Function Impact
Diary (MPFID) tool, and 75% and 100% responder rates (number of
patients experiencing at least a 75% or 100% reduction in monthly
migraine days compared to placebo.) The safety data are consistent
with previous studies of erenumab to date, showing a placebo-like
safety profile. Full data will be presented at an upcoming
scientific meeting.
"The LIBERTY trial is the only Phase IIIb
anti-CGRP study to demonstrate safety and efficacy in patients who
have repeatedly failed other preventive treatments," said Danny
Bar-Zohar, Global Head of Neuroscience Development for Novartis.
"The results add to the consistent body of evidence for erenumab
across the full spectrum of migraine patients, from those trying
preventive medication for the first time through to those who have
failed multiple therapies and have been suffering for years. We
look forward to making erenumab, the first targeted preventive
option specifically designed for migraine, available to patients as
soon as possible."
Erenumab is the only investigational fully human
monoclonal antibody designed to selectively block the calcitonin
gene-related peptide (CGRP) receptor, which plays a critical role
in migraine activation. Currently available preventive treatments
for migraine have generally been repurposed from other therapeutic
areas and are often associated with poor tolerability and lack of
efficacy[1].
The safety, efficacy and tolerability of erenumab
have been assessed in clinical studies involving more than 3,000
patients, including an ongoing open-label extension up to five
years in duration. Erenumab was the first investigational therapy
targeting the CGRP pathway to have received Food and Drug
Administration (FDA) and European Medicines Agency (EMA) regulatory
filing acceptance. If approved, it will be administered
once-monthly using a self-injection device. Subject to
approval, Novartis and Amgen will co-commercialize erenumab in the
US. Amgen has exclusive commercialization rights to the drug in
Japan and Novartis has exclusive rights to commercialize in the
rest of the world.
About LIBERTY
LIBERTY (NCT03096834) is a Phase IIIb, multicenter, randomized
12-week, double-blind, placebo-controlled study evaluating the
safety and efficacy of erenumab in patients with episodic migraine
(defined in the trial as four to 14 migraine days per month at
baseline) who have failed two to four prior preventive treatments
for migraine. In the study, 246 participants were randomized to
receive erenumab 140mg or placebo during the 12-week double-blind
treatment phase. The primary endpoint was the percentage of
patients with at least 50% reduction of monthly migraine days from
baseline over the last four weeks of the double-blind treatment
phase of the study (weeks 9-12)[2]. The trial 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, 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. It has
been validated in line with US Food and Drug Administration Patient
Reported Outcomes Guidance[3]. Percentages of patients with a 75%
response rate and 100% response rate to erenumab, and safety and
tolerability were also assessed as secondary endpoints.
About erenumab (AMG
334)
Erenumab (AMG 334) is the only investigational treatment
specifically designed to prevent migraine by blocking the CGRP
receptor, which plays an important role in migraine activation.
Erenumab 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 our clinical trial program across the four
placebo-controlled Phase II and Phase III clinical studies and
their open-label extensions.
About Migraine
Migraine is a distinct neurological disease[4]. It involves
recurrent attacks of moderate to severe head pain that is typically
pulsating, often unilateral and associated with nausea, vomiting
and sensitivity to light, sound and odors[5]. Migraine is
associated with personal pain, disability and reduced quality of
life, and financial cost to society[6]. It has a profound and
limiting impact on an individual's abilities to carry out everyday
tasks, and was declared by the World Health Organization to be one
of the top 10 causes of years lived with disability for men and
women[7]. It remains under-recognized and under-treated[6],[8].
Existing preventive therapies have been repurposed from other
indications and are often associated with poor tolerability and
lack of efficacy, with high discontinuation rates among
patients[1].
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 erenumab (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 erenumab in the U.S. For the migraine
programs, Amgen retains exclusive commercialization rights in the
U.S. (other than for erenumab as described as 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.
Disclaimer
This press release contains forward-looking statements within the
meaning of the United States Private Securities Litigation Reform
Act of 1995. Forward-looking statements can generally be identified
by words such as "potential," "can," "will," "plan," "expect,"
"anticipate," "look forward," "believe," "committed,"
"investigational," "pipeline," "launch," or similar terms, or by
express or implied discussions regarding potential marketing
approvals, new indications or labeling for AMG 334 or the other
investigational or approved products described in this press
release, or regarding potential future revenues from such products
or the collaboration with Amgen. You should not place undue
reliance on these statements. Such forward-looking statements are
based on our current beliefs and expectations regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that AMG 334
or the other investigational or approved products described in this
press release will be submitted or approved for sale or for any
additional indications or labeling in any market, or at any
particular time. Neither can there be any guarantee that the
collaboration with Amgen will achieve any or all of its intended
goals and objectives, or be commercially successful. Nor can there
be any guarantee that AMG 334 or the other investigational or
approved products described in this press release will be
commercially successful in the future. In particular, our
expectations regarding such products, and the collaboration with
Amgen, could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial
results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally;
our ability to obtain or maintain proprietary intellectual property
protection; the particular prescribing preferences of physicians
and patients; global trends toward health care cost containment,
including government, payor and general public pricing and
reimbursement pressures; general economic and industry conditions,
including the effects of the persistently weak economic and
financial environment in many countries; safety, quality or
manufacturing issues; potential or actual data security and data
privacy issues, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US Securities and Exchange
Commission. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press
release as a result of new information, future events or
otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet
these needs: innovative medicines, cost-saving generic and
biosimilar pharmaceuticals and eye care. Novartis has leading
positions globally in each of these areas. In 2016, the Group
achieved net sales of USD 48.5 billion, while R&D throughout
the Group amounted to approximately USD 9.0 billion. Novartis Group
companies employ approximately 121,000 full-time-equivalent
associates. Novartis products are sold in approximately 155
countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1]
Blumenfeld AM et al. Patterns of use and reasons for
discontinuation of prophylactic medications for episodic migraine
and chronic migraine: results from the second international burden
of migraine study (IBMS-II). Headache. 2013
Apr;53(4):644-55.
[2]
ClinicalTrials.gov A Study Evaluating the Effectiveness of AMG 334
Injection in Preventing Migraines in Adults Having Failed Other
Therapies (LIBERTY).
https://clinicaltrials.gov/ct2/show/NCT03096834. Accessed January
2018.
[3] 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.
[4] Migraine
Research Foundation. Migraine Fact Sheet. 2015.
http://www.migraineresearchfoundation.org/fact-sheet.html. Accessed
January 2018
[5] National
Institute for Neurological Disorders and Stroke.
https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page
(link is external). Accessed January 2018
[6] World
Health Organization. Headache disorders.
http://www.who.int/mediacentre/factsheets/fs277/en/ (link is
external). Accessed January 2018
[7] World
Health Organization. Estimates for 2000-2012. Disease Burden.
2012.
[8] 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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