New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity
06 Décembre 2023 - 8:00AM
Business Wire
- AJOVY® (fremanezumab) efficacy and safety demonstrated in
migraine patients with obesity in post hoc analysis of HALO-LTS1
and FOCUS2 phase 3 studies
- Obesity is a known risk factor for migraine and is frequently
associated with an increase in migraine frequency, severity and
disability3
- Data revealed at the 17th European Headache Congress,
Barcelona, Spain
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
announces that a post hoc analysis4 of two phase 3 clinical studies
presented today at the European Headache Congress has shown the
effectiveness of the migraine prevention treatment AJOVY®
(fremanezumab) in reducing migraine attacks in patients with
migraine and co-morbid obesity.
Migraine and obesity are both associated with high levels of
disability3 and both conditions are more prevalent amongst
females5,6. It is estimated that 59% of people in Europe are either
overweight or obese, with almost a quarter (23%) of adults living
with obesity5. A higher body mass index (BMI) is frequently
associated with increased migraine prevalence and severity, and an
increased number of adverse effects3. As such, assessing the
efficacy and safety of migraine preventative treatment in patients
with obesity can help guide migraine management and treatment
decisions.
The post hoc analysis of the HALO-LTS1 and FOCUS2 phase 3
studies compared the safety and efficacy of fremanezumab migraine
preventive treatment in obese migraine patients vs normal weight
migraine patients for a period of 6 months. Obesity was defined as
having a Body Mass Index (BMI) ≥30 kg/m2 (BMI-high, 578 patients),
and normal weight patients with a BMI <30 kg/m2 (BMI-normal,
1859 patients).
The analysis showed that the efficacy of fremanezumab was the
same in migraine patients with BMI-high vs BMI-normal:
- At baseline, monthly migraine days in migraine patients with
BMI-high vs BMI-normal were 13.7 vs 13.6 respectively.
- After 6 months of treatment with fremanezumab, monthly migraine
days in migraine patients with BMI-high vs BMI-normal was reduced
to 6.8 vs 7.2 respectively.
Furthermore, adverse events (AEs) in patients with obesity were
similar to AEs in non-obese patients treated with fremanezumab.
Lead study author, Consultant Neurologist Dr Pablo Irimia
Sieira, of Clinica Universidad de Navarra, Pamplona, Spain said:
“This analysis is encouraging as it shows fremanezumab can reduce
migraine attacks as effectively in obese patients as it does in
patients of normal weight. Considering the higher burden of
migraine in patients with co-morbid obesity, it is important for
treatments to demonstrate efficacy and safety in migraine patients
with this particular comorbidity.”
Dr. Dieter Schultewolter, Vice President of Global Medical
Affairs Neuroscience at Teva said: “We are seeing clinicians moving
towards more personalised treatment decisions in migraine, which
are tailored to the patient’s profile. So it is informative to see
that the efficacy of fremanezumab for migraine prevention has now
been demonstrated across multiple subgroups, including those with
older age, obesity, psychiatric comorbidities like depression, and
difficult-to-treat migraine.”7,8,9
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. AJOVY▼ European SmPC can be found
here.
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 and innovative 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 medicines research and
operations supporting our growing portfolio of innovative medicines
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 (fremanezumab) for the treatment of
migraine in adults; our ability to successfully compete in the
marketplace, including our ability to develop and commercialize
competition for our innovative medicines, our ability to achieve
expected results from investments in our product pipeline, our
ability to develop and commercialize additional pharmaceutical
products, our ability to successfully launch and execute our new
Pivot to Growth strategy, including to expand our innovative and
biosimilar medicines pipeline and profitably commercialize the
innovative medicines and biosimilar portfolio, whether organically
or through business development 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, 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 third 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 HALO-LTS,
NCT02638103 2 FOCUS study NCT03308968 3 Westgate CSJ, et al.
Understanding the link between obesity and headache- with focus on
migraine and idiopathic intracranial hypertension. J Headache Pain.
2021;22(1):123. 4 Sieria Pablo, et al. Efficacy and Safety of
Fremanezumab in Patients with Migraine and Obesity: Post Hoc
Analysis of the Phase 3 HALO-LTS and FOCUS Clinical Trails.
Presented at the European Headache Congress December 2023. PO35
Poster 5 WHO Regional European Obesity Report 2022 6 Linda
Al-Hassany, et al. Giving Researchers a Headache – Sex and Gender
Differences in Migraine. Frontiers in Neurology. 2020 7 Nahas SJ,
et al. J Headache Pain. 2021;22:141. 8 Lipton RB, et al. Presented
at AHS 2023; Austin, TX, 15–18 June (P-231). 9 Ferrari MD, et al.
Lancet. 2019;394(10203):1030–1040.
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