Interim data presented at the European Academy
of Neurology 2022 shows that 54.7% of patients in the study had
their monthly-migraine-days reduced by 50% or more over the
six-month period from the start of treatment.
Teva Pharmaceuticals Europe B.V. today announces promising
interim results from its Pan-European Real World study (PEARL),
presented for the first time at the European Academy of Neurology
(EAN) Congress in Vienna, Austria.
The two-year Pan-European Real World (PEARL) prospective,
observational study of AJOVY® (fremanezumab), looks at its
effectiveness in patients with chronic migraine or episodic
migraine, and is an ongoing study sponsored by Teva Pharmaceuticals
Europe BV.1 These findings further offer insight into the treatment
of migraine in real-world clinical practice.
The interim findings were presented by Faisal Mohammad Amin,
Associate Professor of Neurology at the University of Copenhagen,
Denmark. Out of the total planned 1100 patients in PEARL, 389
patients are included in the interim analysis presented. These
findings show that 54.7% of patients in the study had their
monthly-migraine-days reduced by 50% or more, over the six-month
period from the start of treatment. Additionally improvements could
be seen in migraine-related disability in the six-month period
after the first dose.
The study is particularly relevant to clinicians due its patient
cohort, who come from 11 countries and approximately 100 study
centres.1 This patient group illustrates both diverse populations
and also a range of reimbursement settings which are important for
treatment access in Europe.
The study will continue to capture data on effectiveness, and
safety of fremanezumab, as well as the reason for and the outcomes
of stopping and re-starting treatments.
Commenting on the findings, Professor Messoud Ashina, PEARL
Coordinating Investigator from the Danish Headache Center and
Department of Neurology in Rigshospitalet Glostrup, Denmark, said:
“Patients with severe migraine could benefit from preventive
therapy but usage of those treatments is far from optimal. These
interim findings provide real-world evidence of how the burden of
migraine can be reduced when the patient has access to monoclonal
antibodies like fremanezumab – something neurologists around the
world are already seeing in patients who did not respond to
previous preventive treatments.”
Dr. Danilo Lembo, Vice President and Head of EU Medical Affairs
at Teva, said: “The PEARL study is encouraging as these findings
confirm that preventive treatment of chronic and episodic migraine
is appropriate with fremanezumab in a real world setting. Our
commitment to real-world evidence studies helps clinicians to
better understand the lived experience of people with migraine,
support the evolution of best clinical practice and demonstrate the
impact of migraine and what preventive treatments can achieve.”
Dr. Lembo continued: “The real life experience of European
patients being able to access preventive treatment is bleak. Beyond
our own data and research, a recent study from the European
Migraine and Headache Alliance showed that 40% of patients needed
more than five years to access migraine treatments.2 We need real
structural change to come from healthcare systems if we are to
ultimately reduce the burden of migraine.”
Chronic migraine is defined as a headache occurring on 15 or
more days per month for more than three months, which, on at least
8 days per month, has the features of migraine headache;3 episodic
migraine is defined as having headaches on fewer than 15 days a
month.4 The significant personal impact and burden of this severity
of migraine has been shown in many studies including Teva’s own
survey of 12,545 adults with migraine - ‘Beyond Migraine’, in which
45% said migraine impacts their ability to be a good partner and
42% to be a good parent, while 49% said migraine diminished their
ability in the workplace. In terms of broader social impact, 46%
reported hiding migraine from others.5
41 million people in Europe live with migraine6 and the disease
is three times more common in women. Migraine is the second leading
cause of disability in the world and the first among young women.7
Migraine often begins at puberty and mostly affects people aged
between 35 and 45 years.8 It strikes during people’s most
productive years (late teens to 50s).9
-ends-
About PEARL
The Pan-European Real World (PEARL) study will generate
important information about real-world effectiveness of
fremanezumab in adult patients with chronic migraine or episodic
migraine (EM). PEARL is an ongoing, 24-month, multicentre,
prospective, observational, Phase IV study.
PEARL will evaluate:
- Effectiveness
- Treatment adherence and persistence
- Effectiveness in patients switching from another mAb targeting
the CGRP pathway
- Concomitant preventive and acute migraine medication use
About AJOVY ▼ (fremanezumab-vfrm) injection
AJOVY is indicated for prophylaxis of migraine in adults who
have at least 4 migraine days per month. AJOVY is available as a
225 mg/1.5 mL single dose injection in a pre-filled syringe or, in
some countries, in a pre-filled pen. Two dosing options are
available: 225 mg once monthly administered as one subcutaneous
injection (monthly dosing), or 675 mg every three months (quarterly
dosing), which is administered as three subcutaneous
injections.
AJOVY can be administered either by a healthcare professional or
at home by a patient or caregiver. No starting dose is required to
begin treatment.
Information for Europe about AJOVY can be found
here.
▼This medicinal product is subject to additional monitoring.
This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse
events. Information can be found at https://www.hpra.ie.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic,
biosimilar and specialty medicines with a portfolio consisting of
over 3,500 products in nearly every therapeutic area. Around 200
million people around the world take a Teva medicine every day and
are served by one of the largest and most complex supply chains in
the pharmaceutical industry. Along with our established presence in
generics, we have significant innovative research and operations
supporting our growing portfolio of specialty and biopharmaceutical
products. Learn more at www.tevapharm.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, which are based on management’s current beliefs and
expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. You
can identify these forward-looking statements by the use of words
such as “should,” “expect,” “anticipate,” “estimate,” “target,”
“may,” “project,” “guidance,” “intend,” “plan,” “believe” and other
words and terms of similar meaning and expression in connection
with any discussion of future operating or financial performance.
Important factors that could cause or contribute to such
differences include risks relating to the commercial success of
AJOVY; our ability to successfully compete in the marketplace,
including our ability to develop and commercialize
biopharmaceutical products, competition for our specialty products,
including AUSTEDO®, AJOVY and COPAXONE®; our ability to achieve
expected results from investments in our product pipeline, our
ability to develop and commercialize additional pharmaceutical
products, and the effectiveness of our patents and other measures
to protect our intellectual property rights; our substantial
indebtedness; our business and operations in general, including
uncertainty regarding the COVID-19 pandemic and the governmental
and societal responses thereto; our ability to successfully execute
and maintain the activities and efforts related to the measures we
have taken or may take in response to the COVID-19 pandemic and
associated costs therewith; costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject or
delays in governmental processing time due to travel and work
restrictions caused by the COVID-19 pandemic; compliance,
regulatory and litigation matters, including failure to comply with
complex legal and regulatory environments; other financial and
economic risks; and other factors discussed in our Quarterly Report
on Form 10-Q for the first quarter of 2022 and in our Annual Report
on Form 10-K for the year ended December 31, 2021, including in the
section captioned “Risk Factors.” Forward-looking statements speak
only as of the date on which they are made, and we assume no
obligation to update or revise any forward-looking statements or
other information contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
___________________
References:
1 Ashina, M. et al, PEARL study protocol. Pain management,
11(6), 647–654. (v0.1) - The two year Pan-European Real World
(PEARL) prospective, observational study of AJOVY®
(fremanezumab)
2 KPMG, prepared for the European Migraine and Headache Alliance
(EMHA). “Access to Care” project: final assessment. July 2021.
[online] Available at:
https://www.emhalliance.org/wp-content/uploads/ATC-EMHA-Dossier.pdf
3 Headache Classification Committee of the International
Headache Society (IHS) The International Classification of Headache
Disorders, 3rd edition. (2018). Cephalalgia, 38(1), 1–211.
https://doi.org/10.1177/0333102417738202
4 Lipton, R. B., & Silberstein, S. D. (2015). Episodic and
chronic migraine headache: breaking down barriers to optimal
treatment and prevention. Headache, 55 Suppl 2, 103–126.
https://doi.org/10.1111/head.12505_2
5 Beyond Migraine – The Real You. Survey conducted 2020. Teva
Pharmaceuticals. Data on file.
6 Stovner, L. J., Andrée, C., & Eurolight Steering Committee
(2008). Impact of headache in Europe: a review for the Eurolight
project. The journal of headache and pain, 9(3), 139–146.
https://doi.org/10.1007/s10194-008-0038-6
7 Steiner, T.J., Stovner, L.J., Jensen, R. et al. Migraine
remains second among the world’s causes of disability, and first
among young women: findings from GBD2019. J Headache Pain 21, 137
(2020). https://doi.org/10.1186/s10194-020-01208-0
8 Who.int. 2016. Headache disorders. [online] Available at:
https://www.who.int/news-room/fact-sheets/detail/headache-disorders
9 EMHA. 2021. Migraine in the EU – Bringing women out of the
shadows. [online] Available at:
https://www.emhalliance.org/wp-content/uploads/Women-M-Policy-Paper-FINAL23MARCH.pdf
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Fiona Cohen, Teva Corporate Communications Europe: +31 6 2008
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