Teva Pharmaceuticals Announces FDA Approval of AJOVY for Pediatric Migraine Prevention Following Positive SPACE Trial Results

• AJOVY demonstrated efficacy and a consistent safety profile in the SPACE trial, making it the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option for both pediatric and adult patients. ^{1 ,2}
• Results from the SPACE trial found AJOVY significantly reduced monthly migraine days and monthly headache days versus placebo over a 12-week period in pediatric patients with episodic migraine. ¹
• The U.S. Food and Drug Administration (FDA) approved AJOVY in August 2025 for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more, building on its initial approval for the preventive treatment of migraine in adults. ²
  
  

PARSIPPANY, N.J. and TEL AVIV, Israel, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the New England Journal of Medicine (NEJM) has published pivotal Phase 3 data on AJOVY, highlighting its efficacy and safety in children and adolescents with episodic migraine. The data from the SPACE study supported the FDA approval of AJOVY for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years weighing 45 kilograms (99 pounds) or more, making it the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for preventive treatment of episodic migraine in pediatric patients and migraine in adults. ^1,2

"With an estimated 1 in 10 children and adolescents in the U.S. living with migraine, the need for effective preventive options is critical as this condition can disrupt daily life for patients and families," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. ³ "The SPACE trial results published in the New England Journal of Medicine add to the growing body of evidence supporting AJOVY and build on its established use in adults. Teva is proud to be leading the charge and continuing to innovate for the migraine community."

In the SPACE trial, AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo (difference: 1.1 days; P = 0.02) and reduced monthly headache days (MHD) of at least moderate severity by 2.6 days versus 1.5 days (difference: 1.1 days; P = 0.02). A significantly higher proportion of participants achieved a ≥ 50% reduction in MMD (47.2%) with AJOVY compared to placebo (27.0%) ( P = 0.002). No new safety signals were identified, and the safety profile remained consistent with that observed in adult studies. ¹

The 3-month, randomized, placebo-controlled SPACE study enrolled 237 children and adolescents aged 6-17 years with episodic migraine. Participants were randomized to receive monthly subcutaneous injections of fremanezumab (120 mg for those weighing < 45 kg; 225 mg for those weighing ≥ 45 kg) or matched placebo. ¹

"Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability and overall social well-being," said the study’s lead author, Andrew D. Hershey, M.D., Ph.D., and Endowed Chair and Director of Neurology at Cincinnati Children’s Hospital Medical Center. "The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population."

For more information on the SPACE study results published online in the New England Journal of Medicine , click here .

About Migraine

Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks. ⁴ Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities. ⁵

About SPACE

SPACE is a multicenter, randomized, 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 preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. AJOVY can be administered either by a healthcare professional or at home by a patient 13 years of age or older or caregiver. No starting dose is required to begin treatment. For full prescribing information, visit https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf

INDICATION AND USAGE

AJOVY is indicated for:

• the preventive treatment of migraine in adults, and
• the preventive treatment of episodic migraine in pediatric patients who are 6 to 17 years of age and who weigh 45 kg or more.
  
  

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy .

Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting.

Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted .

Raynaud’s Phenomenon : Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.

AJOVY should be discontinued if signs or symptoms of Raynaud’s phenomenon develop. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, 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-vfrm) injection 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 other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the third quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, 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. Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo‑Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine. New England Journal of Medicine .
2. AJOVY (fremanezumab-vfrm) injection, for subcutaneous use. Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
3. Al Khalili Y, Asuncion RMD, Chopra P. Migraine Headache in Childhood. [Updated 2023 Mar 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557813/
4. Jaimie D Steinmetz, Katrin Seeher, Nicoline Schiess, Emma Nichols, Bochen Cao, Chiara Servili, Vanessa Cavallera, Christopher J L Murray, Kanyin Liane Ong, Valery L Feigin, Theo Vos, and Tarun Dua on behalf of the GBD network. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Neurol. (in press).
5. 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
   
   

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