Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that data from the Phase IIIb FOCUS study, which evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate response to two to four classes of migraine preventive treatments, will be available at the 13th European Headache Federation (EHF) Congress. This European Congress for healthcare professionals aims to improve the lives of patients affected by migraine by presenting new scientific evidence on migraine prevention, associated comorbidities and the pathogenesis of migraine. EHF is taking place at the ‘Megaron’ Athens International Conference Centre (MAICC), Athens, Greece on May 30th - June 1st 2019.
The FOCUS study is the largest study to date in patients who inadequately responded to multiple classes of preventive migraine treatments. It is the first study of its type to be conducted in chronic as well as episodic migraine patients.
Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva said: “Patients with inadequate response to multiple migraine preventive treatment classes have significant unmet need for the management of their disabling migraine. The FOCUS study results demonstrate the benefit of fremanezumab in addressing the burden of disease in this difficult-to-treat patient population. Teva is committed to meet the needs of migraine patients and their families and we will explore undertaking Phase IV studies with fremanezumab in order to increase our understanding of the disease.”
Professor of Neurology and Chair of the Leiden Centre for Translational Neuroscience at Leiden University Medical Centre, Michel D. Ferrari, MD, PhD, FANA, FRCP said: “The FOCUS study data convincingly show that patients with difficult to treat migraine, previously not responding to up to four migraine preventive treatment classes, might still benefit significantly from treatment with fremanezumab. I am delighted that this data will be presented for the first time at the EHF Congress in Athens.”
In the FOCUS study, patients treated with fremanezumab experienced significant reduction in the monthly average number of migraine days versus placebo over the 12-week treatment period, for both monthly and quarterly dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. Teva will also host a satellite symposium on Friday during the congress.
Notes to the Editor
The full set of Teva-sponsored data to be presented includes:
12.00pm – 12.15pm
Presenter: Prof. Messoud Ashina
Efficacy and safety of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.
14.45pm – 15.00pm
Presenter: Prof. Richard Lipton
Long-term efficacy of fremanezumab in patients who reverted from a chronic to an episodic migraine classification.
15.00pm – 15.15pm
Presenter: Joshua M. Cohen
Efficacy, clinically meaningful responses, and impact on acute headache medication use with fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.
The FOCUS Study provides data in migraine patients who responded inadequately to two to four classes of prior migraine preventive medications.
Titles of the presentations include:
The following presentations will be presented:
Migraine Burden in Europe: What Role Can Innovations Play ?
Chair: Professor Dimos D. Mitsikostas, MD, PhD, FEAN
Friday 31 st May, 15:45 – 17:00, ‘Megaron’ Athens International Conference Centre (MAICC), Alexandra Trianti Hall
Educational Symposium Program Overview:
Migraine remains a leading cause of disability in the European Union (EU) and is associated with a substantial economic and societal burden. However, the recent introduction of monoclonal antibodies (mAbs) that target calcitonin gene-related peptide into the treatment armamentarium offers a potential means to ease the burden of migraine on both patients and the EU healthcare system. This program will examine the epidemiology of migraine, along with its social and financial impacts; explain the scientific advancements behind the clinical utility of mAbs; and discuss findings from 2 clinical studies of the mAb fremanezumab for migraine prevention; a long-term study and a study in patients with refractory episodic and chronic migraine.
The full online programme can be accessed via the congresses official website: https://www.ehf2019.com/calendar
The Phase IIIb FOCUS study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to two to four classes of prior preventive treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at least three months of therapy at a stable dose; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients were randomized in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months (weeks 13-24) followed the placebo-controlled portion of the study.
Migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting.i With more than 1 billion people affected worldwidei, migraine is the third most prevalent disease in the world.ii
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 specialty medicines with a portfolio consisting of over 35,000 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
Teva 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 regarding Fremanezumab (commercialized as AJOVY ® ▼), 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. Important factors that could cause or contribute to such differences include risks relating to:
|▼ Adverse events should be reported.|
|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.|
Reporting forms and information can be found at https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Teva – please refer to local numbers.
i Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/.
Accessed November 2018.
ii Migraine Trust. Facts and Figures. https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/. Accessed November 2018.
Fiona Cohen +31 6 2008 2545
Doris Saltkill +1(913)777-3343