New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity

Rhea-AI Summary

Teva Pharmaceutical Industries Ltd. (TEVA) reports that a post hoc analysis of two phase 3 clinical studies presented 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. The analysis 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. After 6 months of treatment, monthly migraine days in migraine patients with high BMI was reduced to 6.8 vs 7.2 for normal weight patients. Adverse events in patients with obesity were similar to non-obese patients treated with fremanezumab.

Positive

• AJOVY® (fremanezumab) has shown effectiveness in reducing migraine attacks in patients with co-morbid obesity
• The efficacy of fremanezumab was the same in migraine patients with high BMI vs normal weight
• Monthly migraine days in migraine patients with high BMI was reduced to 6.8 vs 7.2 for normal weight patients after 6 months of treatment

Negative

• None.

• 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 17^th European Headache Congress, Barcelona, Spain

TEL AVIV, Israel--(BUSINESS WIRE)-- 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 females^5,6. 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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Source: Teva Pharmaceutical Industries Limited

FAQ

What are the findings of the post hoc analysis of the HALO-LTS1 and FOCUS2 phase 3 studies presented at the European Headache Congress?

The analysis showed the effectiveness of AJOVY® (fremanezumab) in reducing migraine attacks in patients with migraine and co-morbid obesity.

How does fremanezumab compare in efficacy between obese migraine patients and normal weight patients?

The efficacy of fremanezumab was the same in migraine patients with high BMI vs normal weight.

How did the monthly migraine days change after 6 months of treatment with fremanezumab for migraine patients with high BMI?

Monthly migraine days in migraine patients with high BMI was reduced to 6.8 vs 7.2 for normal weight patients.

What were the findings regarding adverse events in patients with obesity treated with fremanezumab?

Adverse events in patients with obesity were similar to non-obese patients treated with fremanezumab.

What is AJOVY® (fremanezumab) and what is its intended use?

AJOVY® (fremanezumab) is a humanized monoclonal antibody developed by Teva Pharmaceuticals, approved for the prevention of migraine in adults who have at least 4 migraine days per month.