New Post Hoc Phase 3 Data Analysis Shows AJOVY ® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity
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 females5,6. 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.
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.
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Eden Klein +972 (3) 906 2645
Fiona Cohen +31 6 2008 2545
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
VeriSilicon NPU IP is Shipped in Over 100 Million AI-Enabled Chips Worldwide29.2.2024 01:00:00 CET | Press release
VeriSilicon (688521.SH) today announced that it has reached a milestone achievement with its Neural Network Processor (NPU) IP integrated into over 100 million AI-enabled chips across 10 major application sectors worldwide, including Internet of Things (IoT), wearables, smart TVs, smart home, security monitoring, servers, automotive electronics, smartphones, tablets, and smart healthcare. As a global leader in embedded AI/NPU over the past seven years, VeriSilicon’s NPU IP has been successfully integrated into 128 AI SoCs supplied by 72 licensees in these varied market segments. VeriSilicon’s NPU IP is a high-performance AI processor IP designed with a low-power, programmable, and scalable architecture. It can be easily configured to meet licensees’ requirements for chip sizes and power budgets, making it a cost-effective neural network acceleration engine. This IP also ships with extensive and mature Software Development Kit (SDK) supporting all major deep learning frameworks, ensurin
Terra Firma Energy Limited Secure 120MW of Contracts From Record Breaking T-4 Capacity Market Auction28.2.2024 20:07:00 CET | Press release
Terra Firma Energy have successfully secured 120MW of contracts in the record-breaking T-4 Capacity Market auction. After two bidding rounds the auction cleared at £65/kW/Year breaking last year’s record of £63/kW/Year. This outstanding result will see our contracted assets receive over £7.3M per year to be on standby to provide critical support to National Grid when required. UK Capacity Market The UK Capacity Market ensures electricity supply meets demand, especially during peak times, by incentivising generation investment and maintaining grid stability. Auction results determine prices paid to generators for ensuring electricity availability. The T-4 auction secures capacity for delivery in four years via long-term 15-year agreements, while T-1 auctions procure capacity just before delivery via 12-month agreements. On February 27, 2024, the T-4 auction cleared at £65/kW/year for delivery in Oct-2027/Sep-28. William Davies, Managing Director of Terra Firma Energy said “I am thrilled
Verimatrix Streamkeeper Wins Gold in 2024 Merit Awards for Telecom Innovation28.2.2024 19:14:00 CET | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced that its Verimatrix Streamkeeper took home top honors in this year’s Merit Awards for Telcom and Wireless. The gold win in the Security Innovations category marks the latest in a growing stack of industry recognitions marking Streamkeeper’s uniquely powerful and multi-layered anti-piracy protection capabilities. Judged by industry executives, members of the media and consultants as well as Merit Awards staff, the program is dedicated to recognizing the efforts put forth by global industries and the markets they serve, acknowledging companies that have contributed to the continued growth of the market. Verimatrix Streamkeeper combines digital content security with app protection to hunt down and take down piracy for many of the world’s entertainment leaders – including more than half a billion clients across devices. "We are thrilled to con
Tecnotree's Comprehensive Next-Generation BSS Solutions to Drive Nuh Digital’s Transformation28.2.2024 17:07:00 CET | Press release
Tecnotree, a global digital platform and services leader for AI, 5G, and cloud-native technologies, announced the signing of a new digital transformation deal with Nuh Digital, to provide BSS stack solutions to enhance the company’s operational efficiency and meet current and future market requirements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240228266983/en/ (Graphic: Business Wire) Nuh Digital is a growing Mobile Virtual Network Operator (MVNO), changing the scenario of digital inclusion in Brazil, with the purpose of developing businesses through innovation and intelligent connectivity. Tecnotree’s digital marketplace solutions will enable the company to introduce new digital services quickly and cost-effectively. The full digital stack deployment will include Mediation, Provisioning, BSS Switch (Convergent Billing Solution, Customer Lifecycle Manager, Unified Product Catalog, Enterprise Integration Accelerator), D
LiveRamp Launches Unified Data Collaboration Platform Featuring Composable Technology28.2.2024 17:00:00 CET | Press release
LiveRamp (NYSE: RAMP) today unveiled the next generation of the /LiveRamp Data Collaboration Platform, which brings together solutions for the end-to-end marketing lifecycle onto a single platform. The unified offering introduces new capabilities such as a simplified user interface, composable technology for cross-cloud interoperability, and a partner marketplace where innovative third-party developers can build applications showcasing their trusted expertise. Built on a foundation of durable, authenticated technology designed to withstand signal loss, the /LiveRamp Data Collaboration Platform offers functionality to proactively address evolving privacy considerations while accelerating forward-looking data collaboration use cases. Gartner® findings show “Marketing has an outsized role in data and analytic activities across the enterprise, with 71% of marketing data and analytics teams responsible for owning at least one element of data strategy for their organization.” By bringing all