Teva’s Phase IV UNITE Study Shows AJOVY® (Fremanezumab) Reduces Migraine Attacks and Depression Symptoms in Migraine Sufferers with Major Depressive Disorder – LeLézard.com

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Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announce that data from the UNITE study presented today at the World Neurology Congress in Montreal, Canada show that AJOVY (fremanezumab) reduces migraine attacks and depression symptoms in migraine sufferers suffering from severe suffering from depressive disorder, reduced. AJOVY is currently approved for the preventive treatment of migraines in adults.

Depression is one of the most common psychiatric comorbidities in migraine, and patients with comorbid depression are at increased risk of migraine chronification.1 This is characterized by an increase in the number of headache days, a higher degree of headache-related disability, a decrease in quality of life and poorer response to migraine Migraine treatments.2,3,4,5

UNITE6 is a Teva-sponsored, double-blind, randomized, placebo-controlled Phase 4 study evaluating the efficacy, safety and effect of fremanezumab in patients with migraine and major depressive disorder.

Data revealed in an oral presentation by Verena Ramirez Campos, Global Senior Medical Director at Teva, showed that study patients treated with fremanezumab experienced a significant reduction in monthly migraine days (MMD) compared to patients on placebo, i.e. a reduction in MMD by – 5.1 versus -2.9 for fremanezumab compared to placebo (p

In response to this data, Verena Ramirez Campos said: Patients suffering from migraines and mental disorders such as depression are exposed to a much greater burden than those who only suffer from migraines or depression. Data from the UNITE study presented at the WCN conference provide additional information about the potential efficacy, safety and quality of life of AJOVY in people with migraine and major depressive disorder.

Two additional data sets were presented as posters on the study’s secondary endpoints, which assessed the effects of fremanezumab on depression8 and disability.9

Fremanezumab treatment resulted in a significant reduction in depression symptoms as measured by two commonly used depression assessment scores. The mean change at week 12 for fremanezumab and placebo using the Hamilton Depression Rating Scale (HAM-D 17), respectively, was -6.7 versus -5.4 (p = 0.0228) and using the Patient Health Questionnaire-9 (PHQ-9) scores were -7.8 and -6.3, respectively (p=0.0108).

Fremanezumab also demonstrated clinically meaningful improvements in disability outcomes in study patients, with sustained reductions in disability over time. The mean change at week 12 for fremanezumab and placebo was -8.8 versus -5.2 (p?0.0001) using the Headache Impact Test (HIT-6) score and using the Clinical Score, respectively. Global Impression-Severity (CGI-S) was -1.1 versus -0.8 (p=0.0030), respectively.

These encouraging results suggest that fremanezumab has the potential to reduce the symptoms and cumulative burden of migraine and related depression.

The study’s lead author, Richard Lipton of the Department of Neurology, Psychiatry and Behavioral Sciences at the Albert Einstein College of Medicine in New York, said: “Depression is often associated with migraines and doctors are increasingly aware of the impact of comorbidities.” We are moving towards more personalized migraine treatment decisions tailored to the patient profile, and it is very important that the treatments demonstrate their effectiveness and safety in migraine patients with this particular comorbidity.

AJOVY (fremanezumab), a humanized monoclonal antibody developed by Teva Pharmaceuticals, selectively targets the calcitonin gene-related peptide (CGRP) and is approved for the prevention of migraine in adults with at least 4 migraine days per month.

NOTES FOR EDITORS

About AJOVY? (frmanzumab-vfrm) injection

AJOVY is indicated for migraine prophylaxis in adults who experience at least 4 migraine days per month. AJOVY is available as a single-dose injection of 225 mg/1.5 ml in a pre-filled syringe or, in some countries, a pre-filled pen. Two dosage options are available: 225 mg once a month in one subcutaneous injection (monthly dosing) or 675 mg every three months (quarterly dosing) in three subcutaneous injections. AJOVY can be administered by a healthcare professional or at home by the patient or caregiver. No starting dose is required to start treatment.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and manufacturing medicines to improve people’s lives for more than a century. We are a leading global provider of generics, biosimilars and specialty medicines with a portfolio of more than 3,500 products in almost all therapeutic areas. Approximately 200 million people worldwide take a Teva drug every day, served by one of the largest and most complex supply chains in the pharmaceutical industry. In addition to our established presence in generics, we conduct significant innovative research and activities to support our growing portfolio of specialty and biopharmaceutical products. To learn more, visit www.tevapharm.com

Be careful with 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 significant known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ materially and those expressed or implied by these forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “objective,” “may,” “project,” “guess,” “intend,” “plan.” , “believe” and other important words and terms. and similar expressions in the context of any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks associated with the development and commercial success of AJOVY, our ability to compete successfully in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition from our medicines, including AUSTEDO, AJOVY, UZEDYTM and COPAXONE, our ability to achieve the expected results of investments in our product portfolio, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures protecting our intellectual property rights; our significant indebtedness, which could limit our ability to incur additional debt, complete additional transactions or make new investments, which could result in a further downgrade of our credit rating; our business and operations generally, including the impact of, and governmental and societal responses to, global economic and other macroeconomic developments and the costs and delays resulting from the comprehensive drug regulation to which we are subject; compliance, regulatory and litigation issues, including the inability 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 our Annual Report on Form 10-K for the year ended December 31, 2022, including the section entitled “Risk Factors.” Forward-looking statements speak only as of the date they are made, and we undertake 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. We caution you not to place undue reliance on these forward-looking statements.

References:

1 Minen MT, et al. Migraine and its psychiatric comorbidities. J Neurol Neurosurgical Psychiatry. 2016; 87:741?749.

2 Lipton RB, et al. Migraines, 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 the associated risk of increasing headache intensity and frequency: results from the MAST (Migraine in America Symptoms and Treatment) study. J headache. 2020; 9:23 p.m.

4 Heckman BD, et al. Do psychiatric comorbidities affect headache treatment outcomes? Results of a naturalistic longitudinal treatment study. Bread. 2009; 146:56-64.

5 Walter S, Bigal ME. TEV-48125: a review of an investigational CGRP monoclonal antibody for the preventative 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 trial. Present at the 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 from the UNITE trial. Present at the 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 from the UNITE trial. Present at the World Congress of Neurology (WCN); 15-19. October 2023; Montreal.

The text of the press release resulting from a translation should in no way be considered official. The only authentic version of the Communiqué is the Communiqué in its original language. The translation must always be compared with the source text, which establishes the case law.

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