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
TEL AVIV, Israel--(BUSINESS WIRE)-- 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.
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
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.
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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In the middle of our Zoom interview, Mati Gill, Tel Aviv-based CEO of venture studio AION Labs, excused himself calmly to find shelter when a siren started to run amok in the background. After five minutes, he returned and said: “I have to show an example for the kids — so I can’t skip out on running to the shelter.”
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Given the fate of the partners’ Humira biosim and the fallout from Alvotech’s FDA inspection in March, the latest rejection wasn't a complete surprise.
Even as Teva Pharmaceuticals’ Icelandic counterpart Alvotech works to get its Reykjavik manufacturing facility back up to snuff, lingering problems at the plant—which derailed approval of the partners’ Humira biosimilar earlier this year—have triggered another FDA rejection.
This time, the FDA action hits the partners' proposed copycat of Johnson & Johnson’s top-selling drug Stelara.
The silver lining? Teva and Alvotech still have plenty of time to sort things out, thanks to a recent settlement with J&J that permits the biosimilar makers to launch their version of the inflammatory disease blockbuster no later than Feb. 21, 2025.
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Upon resubmitting AVT04’s approval filing, Alvotech expects the FDA will likely take another six months to review its Stelara biosimilar.
Meanwhile, Alvotech is already looking forward to its next visit from the U.S. drug regulator, according to the company’s chairman and CEO Robert Wessman. Based on latest communications with the FDA, Alvotech expects the agency will reinspect its Reykjavik plant at the start of 2024, Wessman said in a statement.
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In April, Teva and Alvotech received a second complete response letter rejecting AVT02, along with another Form 483 from the FDA singling out issues at Reykjavik pertaining to quality shortfalls, subpar written records, problems with incoming stoppers and insufficient computer controls, among other manufacturing gaps.
AVT02 was rejected once again in late June, also due to concerns around Alvotech’s facility.
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