Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial

  • AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in pediatric patients aged 6-17 years1
  • Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
  • Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands

TEL AVIV, Israel, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented positive data from its Phase 3 SPACE study evaluating the efficacy and safety of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years.1 The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favourable safety profile1 consistent with that observed in the adult population.

Migraine is common among children, with an overall estimated prevalence of 7.7%.2 The prevalence increases from 5% among children aged 5 to 10 years-old to approximately 15% among adolescents.2 Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.2

One of the lead investigators of the trial, Professor Patricia Pozo-Rosich, Headache Unit and Research Group, Head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute, Barcelona said “This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them. This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with favourable safety and tolerability for the prevention of episodic migraine in children and adolescents.”

SPACE is a multicentre, double-blind study evaluating the efficacy and safety of fremanezumab in 237 children and adolescents with episodic migraine aged 6-17 years. The pediatric study participants had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days a month. The trial included subgroup analyses by age (6 -11 years and 12 -17 years) and by sex.1

Highlights from the SPACE data showed that over 3 months fremanezumab achieved:1

  • Significant reduction in monthly migraine days (MMD) vs placebo (-2.5 vs -1.4; p=0.0210)
  • Significant reduction in monthly headache days (MHD) vs placebo (-2.6 vs -1.5; p=0.0172)
  • Significantly higher number of children achieving a 50% response rate vs placebo (47.2% vs 27.0%; p=0.0016)
  • Benefits were similar in both the age subgroups and between boys and girls

Fremanezumab also demonstrated a favourable safety profile, and was well tolerated with no safety signals:1  

  • Proportion of children reporting ≥1 adverse events (AEs) was similar between the treatment group vs placebo (55% vs 49%)
  • Proportion of patients with serious adverse events (SAEs) and AEs leading to treatment discontinuation was low at ≤3% and ≤1% respectively

“Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licenced treatments to manage this debilitating condition in children.” said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals. 'We’ve already seen the benefits of AJOVY in adults and the SPACE trial has confirmed that children with episodic migraine can also benefit from AJOVY. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden.”

Teva continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.

About SPACE

SPACE is a multicentre, randomised, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety, and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12 week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.  

About AJOVY®

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.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit 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: our ability to successfully develop and commercialize AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescents ; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our 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 to sustain and focus our portfolio of generics medicines; and other factors discussed in this press release, in our quarterly report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections 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 Hershey, A., et al. Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic Migraine in Children and Adolescents: a Phase 3, Randomised, Double-Blind, Placebo-Controlled Study. Presented at European Headache Congress (EHC); 4-7 December 2024, Rotterdam. ePoster LP036.

2 Pediatric Migraine, An Update. Greene, Kaitlin. et al; Neurology clinics, Volume 37, Issue 4, 815-833. August 31, 2019. https://doi.org/10.1016/j.ncl.2019.07.009

IR Contacts Chris Stevo+1 (339) 213-3999
  Yael Ashman+972 (3) 914 8262
  Sanjeev Sharma+1 (973) 658 2700 
Media Contacts Kelley Dougherty+1 (973) 832-2810
  Eden Klein+972 (3) 906 2645  

Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial


THỦ THUẬT HAY

Nên chọn laptop dùng card AMD hay NVidia?

Ở bài viết này, chúng ta sẽ cùng tìm hiểu về 2 loại card màn hình laptop thông dụng trên thị trường: NVidia vs AMD, để xem bạn nên lựa chọn hãng nào nhé.

Xuất dữ liệu danh bạ từ iPhone ra file Excel đơn giản với Contacts 2 XLS

Quá trình xuất dữ liệu danh bạ từ iPhone ra file Excel cũng khá là đơn giản và hoàn toàn miễn phí với ứng dụng Contacts 2 XLS trên App Store. Bài viết dưới đây sẽ hướng dẫn bạn chi tiết các bước thực hiện.

Học cách kiếm tiền bằng Google Rewards trên Android

Google Rewards là ứng dụng miễn phí trên Play Store. Sau khi tải và mở ứng dụng lần đầu tiên, Google sẽ yêu cầu bạn trả lời vài câu hỏi về bản thân. Chúng rất dễ trả lời. Mục đích của chúng nhằm giúp công cụ tìm kiếm

Cách tạo dòng trạng thái Facebook với phong cách viết tay siêu đẹp

Gần đây, phong trạo tạo dòng trang thái theo phong cách viết tay trở nên khá phổ biến. Điều này làm cho dòng trạng thái của bạn trở nên độc đáo và bắt mắt hơn thu hút nhiều người xem hơn. Hôm nay, ĐIỆN MÁY XANH sẽ

Tự động tắt âm thanh khi tháo tai nghe trên Windows

Bạn thường xuyên nghe nhạc cũng như xem phim trên máy tính, laptop tuy nhiên, mỗi lần bạn rút tai nghe ra là âm thanh lại cứ thế tiếp tục phát hoặc phát trên loa ngoài khiến bạn và người xung quanh khó chịu (đặc biệt

ĐÁNH GIÁ NHANH

Trên tay iPhone 13: Thay đổi nhỏ trong thiết kế, pin lớn hơn

Trong thời gian chờ đợi iPhone 13 chính thức bán ra và có mặt tại Việt Nam, bạn hãy cùng mình trên tay iPhone 13 và khám phá những điểm hấp dẫn trên chiếc flagship mới này của Apple nhé. iPhone 13 là bản tiêu chuẩn với

Đánh giá chất lương hình ảnh thự tế từ camera của Galaxy Note9

Đầu tiên, chúng ta sẽ điểm lại thông số kỹ thuật trên bộ đôi camera Galaxy Note 9. Giống như người đàn anh S9 Plus, mẫu phablet cao cấp mới ra mắt của Samsung cũng sở hữu cụm camera sau nằm ngang với tính năng khẩu độ

Có nên mua iPad mini 6 không?5 lý do dưới đây sẽ giúp bạn giải đáp

iPad mini 6 được Apple trình làng cùng iPhone 13 series hồi tháng 9 và hiện đã lên kệ tại nhiều quốc gia. Thuộc thương hiệu cao cấp nhưng không ít bạn vẫn đắn đo có nên mua iPad mini 6 không. Bài viết này sẽ đưa ra 5