These results include reduction in monthly average migraine days; reduction in migraine related symptoms; and improvements in depression status; work productivity and activity impairment.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today is proud to present the FOCUS exploratory endpoints results at the 5th Congress of the European Academy of Neurology (EAN), Oslo, Norway from June 29th - July 2nd, 2019.
These endpoints, which were shared for the first time at EAN, conclude the presentation of pre-specified study endpoints from the Phase IIIb FOCUS study. This study evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments.
Director of the Headache Clinical Unit and Research Group at Vall d’Hebron Hospital and Institute of Research (VHIR), Patricia Pozo Rosich, MD, PhD, said: “The FOCUS study results demonstrate the potential of fremanezumab in addressing the burden of migraine in this difficult-to-treat patient population and I am glad to see the exploratory data being presented at EAN which includes quality of life and disability results, which also improved in these patients who have a substantial daily burden due to their migraine.”
“Migraine is the second leading cause of years lived with disability worldwide with profound impact on patients, their families and friends, and on society as a whole. Data from the FOCUS study disclose the results of fremanezumab on a range of quality of life and disability measures as well as demonstrating a significant reduction in the number of headache hours and days suffered by patients and on a spectrum of associated symptoms”, commented Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache.
During the EAN Congress, Teva presented FOCUS exploratory endpoints results which include:
Reduced Migraine Days
Data on efficacy and clinically meaningful responses to fremanezumab showed reductions in the monthly average number of migraine days and sustained ≥50% response rates over three months were significantly greater with fremanezumab versus placebo in the study.
In the FOCUS study data being presented at EAN, both monthly and quarterly fremanezumab dosing reduced migraine-related symptoms of nausea or vomiting and photophobia and phonophobia versus placebo in the study cohort.
The impact of fremanezumab on headache-related disability was assessed using internationally regarded questionnaires as exploratory endpoints of the FOCUS trial. Substantial improvements in headache-related disability were seen in those patients taking the active drug compared with placebo - with both fremanezumab dosing regimens - and reductions from baseline in the disability score were greater compared with placebo.
Quality of Life
Migraine invariably has a negative effect on quality of life and the study looked at the effect of fremanezumab on migraine-specific health-related quality of life and health status in patients as exploratory endpoints. Mean changes from baseline using internationally regarded quality of life questionnaires were seen four weeks after the third dose. Improvements were seen from baseline in all domains, and scores were greater with both fremanezumab dosing regimens versus placebo.
Migraine patients are estimated to be approximately 2-4 times more likely to have depression than the general population. Depression status was evaluated as an exploratory endpoint in the study. Improvements in depression status were observed with monthly fremanezumab versus placebo, and to a lesser degree with the quarterly dose.
Work productivity and activity impairment were evaluated using a globally accepted questionnaire to ascertain whether fremanezumab had a positive impact. During the 4 weeks after the third study drug dose, greater improvements from baseline were observed with both fremanezumab dosing regimens versus placebo (nominal p-values all P<0.05) assessing absenteeism and presenteeism.>0.05)>
The use of any medication, and migraine-specific acute headache medication such as triptans and ergot compounds, respectively, were evaluated and results show that both dosing regimens of fremanezumab significantly reduced acute headache medication use of either kind.
The study also investigated the efficacy of fremanezumab in patients who had previously failed topiramate or onabotulinumtoxinA. Reductions from baseline in the monthly average number of migraine days during the 12-week treatment period were significantly greater with both fremanezumab regimens versus placebo in this subset of patients.
The full results of the FOCUS study will be submitted for publication later in 2019.
The full EAN online programme can be accessed via the congresses official website:
Notes to Editors:
The Phase IIIb FOCUS study of fremanezumab was the first and largest study of a migraine preventive treatment in a difficult-to-treat population of adults with episodic or chronic migraine (EM or CM) who had documented inadequate response to 2-4 classes of migraine preventive medications. The 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 worldwide, 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.
Kevin C. Mannix
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