- Almost half of all migraine patients experience depression and
anxiety1
- Migraine patients treated with AJOVY® (fremanezumab) showed
significant reductions in depressive symptoms and clinically
meaningful improvements in disability outcomes
- Data revealed at the World Congress of Neurology, Montreal,
Canada
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announce that data from the UNITE study presented today at the
World Congress of Neurology in Montreal, Canada, show that AJOVY®
(fremanezumab) reduced migraine attacks and depression symptoms in
migraine patients with major depressive disorder. AJOVY® is
currently approved for the preventive treatment of migraine in
adults.
Depression is one of the most prevalent psychiatric
co-morbidities in migraine and patients with comorbid depression
experience an increased risk of migraine ‘chronification’.1 This is
characterised by an increase in the number of headache days, a
greater degree of headache disability, decreased quality of life
and a poorer response to migraine treatments.2,3,4,5
UNITE6 is a double-blind, randomised, placebo-controlled, Phase
4 study sponsored by Teva investigating the efficacy, safety, and
impact of fremanezumab on patients with migraine and major
depressive disorder.
Data revealed in an oral presentation by Dr Verena Ramirez
Campos, Global Senior Medical Director at Teva, showed that
patients in the study treated with fremanezumab experienced a
significant reduction in Monthly Migraine Days (MMD) compared to
patients on placebo, a reduction in MMD of –5.1 vs –2.9 for
fremanezumab vs placebo (p<0.0001). Furthermore, a significantly
higher number of patients (33%), receiving fremanezumab achieved
≥50% reduction in MMD compared to placebo (13%) during the 12 week
double blind period (p<0.0001), with a sustained reduction over
the longer-term.7
Commenting on the data, Dr. Verena Ramirez Campos said:
“Patients who suffer from migraine and mental health disorders such
as depression face a far greater burden than those suffering from
either migraine or depression alone. The UNITE data presented at
WCN provides further insights into the potential efficacy, safety,
and quality of life benefits of AJOVY® for people with migraine and
major depressive disorder.”
Two further data sets were presented as posters on the study’s
secondary endpoints that evaluated the impact of fremanezumab on
depression8 and disability. 9
Treatment with fremanezumab resulted in significant reductions
in depression symptoms as measured by two commonly used depression
rating scores. The mean change at week 12 for fremanezumab and
placebo using the Hamilton Rating Scale for Depression (HAM-D 17)
was -6.7 vs -5.4 respectively (p=0.0228) and using the Patient
Health Questionnaire-9 (PHQ-9) score was -7.8 vs -6.3 respectively
(p=0.0108).
Furthermore, fremanezumab demonstrated clinically meaningful
improvements in disability outcomes in the study patients with a
sustained reduction in their disability over the longer term. The
mean change at week 12 for fremanezumab and placebo using the
Headache Impact Test score (HIT-6) was -8.8 vs -5.2 respectively,
(p≤0.0001) and using the Clinical Global Impression-Severity
(CGI-S) score was -1.1 vs -0.8 respectively (p=0.0030).
These encouraging results indicate that fremanezumab has the
potential to reduce the symptoms and cumulative burden of migraine
and associated depression.
Study lead author Richard Lipton M.D., Department of Neurology,
Psychiatry and Behavioural Sciences at Albert Einstein College of
Medicine, New York said: “Depression is commonly associated with
migraine, and clinicians are increasingly aware of the impact of
co-morbidities. We are moving towards more personalised treatment
decisions in migraine which are tailored to the patient’s profile,
and it is very important for treatments to demonstrate efficacy and
safety in migraine patients with this particular co-morbidity.”
AJOVY® (fremanezumab), a humanized monoclonal antibody (mAb)
developed by Teva Pharmaceuticals, selectively targets the
calcitonin gene-related peptide (CGRP), and is approved for the
prevention of migraine in adults who have at least 4 migraine days
per month.
NOTES TO EDITORS
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.
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 development and
commercial success of AJOVY; our ability to successfully compete in
the marketplace, including our ability to develop and commercialize
biopharmaceutical products, competition for our innovative
medicines, including AUSTEDO®, AJOVY, UZEDYTM 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 which may limit our ability to incur
additional indebtedness, engage in additional transactions or make
new investments, may result in a further downgrade of our credit
ratings; and our inability to raise debt or borrow funds in amounts
or on terms that are favorable to us; our business and operations
in general, including, the impact of global economic conditions and
other macroeconomic developments and the governmental and societal
responses thereto, and costs and delays resulting from the
extensive pharmaceutical regulation to which we are subject;
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 second quarter of 2023 and in
our Annual Report on Form 10-K for the year ended December 31,
2022, 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 Minen MT, et al. Migraine and its psychiatric comorbidities. J
Neurol Neurosurg Psychiatry. 2016; 87: 741–749. 2 Lipton RB, et al.
Migraine, quality of life and depression. A population-based
case-control study. Neurology. 2000; 55: 629–635. 3 Buse DC, et al.
Comorbid and co-occurring conditions in migraine and associated
risk of increasing headache pain intensity and headache frequency:
results of the migraine in America symptoms and treatment (MAST)
study. J Headache Pain. 2020; 21:23. 4 Heckman BD, et al. Do
psychiatric comorbidities influence headache treatment outcomes?
Results of a naturalistic longitudinal treatment study. Pain. 2009;
146: 56-64. 5 Walter S, Bigal ME. TEV-48125: a review of a
monoclonal CGRP antibody in development for the preventive
treatment of migraine. Curr Pain Headache Rep. 2015; 19:6. 6 UNITE
study protocol NCT04041284. 7 Lipton RB, et al. Efficacy of
fremanezumab treatment in reducing monthly migraine days in
patients with migraine and major depressive disorder: Results from
the UNITE study. Presented at World Congress of Neurology (WCN);
15–19 October 2023; Montreal. 8 Lipton RB, et al. Efficacy of
fremanezumab in reducing depression in patients with migraine and
major depressive disorder: results of the UNITE study. Presented at
World Congress of Neurology (WCN); 15–19 October 2023; Montreal. 9
McAllister P, et al. Impact of fremanezumab treatment on disability
outcomes in patients with migraine and major depressive disorder:
results of the UNITE study. Presented at World Congress of
Neurology (WCN); 15–19 October 2023; Montreal.
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