FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine

Rhea-AI Summary

Teva Pharmaceuticals (NYSE: TEVA) has received FDA approval for an expanded indication of AJOVY® (fremanezumab-vfrm) for preventive treatment of episodic migraine in children and adolescents aged 6-17 years weighing 45kg or more. This milestone makes AJOVY the first and only CGRP antagonist approved for pediatric episodic migraine prevention.

The treatment, which can be administered monthly either in-office or at home, addresses a significant medical need, as 1 in 10 children and adolescents in the U.S. suffer from migraine. This expansion builds upon AJOVY's initial U.S. approval in 2018 for adult patients, demonstrating Teva's commitment to broadening access to neuroscience therapies across age groups.

Positive

• None.

Negative

• Weight requirement limits treatment to patients 45kg (99 pounds) or more
• Limited to episodic migraine prevention only, not approved for chronic migraine in pediatric patients

Insights

Pharmaceutical Analyst

Teva's AJOVY receives FDA approval for pediatric migraine prevention, expanding its market as the first CGRP antagonist for this population.

Teva Pharmaceuticals has secured a significant regulatory milestone with the FDA approval of AJOVY (fremanezumab-vfrm) for preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh at least 45kg. This approval represents a strategic market expansion for Teva's neurology portfolio, positioning AJOVY as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention.

The pediatric migraine market presents a substantial opportunity, with approximately 1 in 10 children and adolescents in the U.S. suffering from migraines. This previously underserved patient population has faced limited preventive treatment options, creating a competitive advantage for Teva as the first-mover in this specific therapeutic space.

From a commercial perspective, AJOVY's once-monthly dosing regimen with flexible administration options (in-office or at-home) addresses adherence challenges in the pediatric population - a critical factor for treatment success and market penetration. This expanded indication builds upon AJOVY's established presence in the adult migraine market since its original FDA approval in 2018.

For Teva's broader business strategy, this approval strengthens its neuroscience franchise and demonstrates the company's commitment to lifecycle management of key products. By targeting younger patients, Teva potentially creates longer-duration therapy opportunities and establishes brand loyalty that could transfer into adulthood, enhancing the product's long-term commercial viability.

• FDA approves single-dose AJOVY^® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh 45 kilograms or more, offering a long-awaited monthly treatment option with in-office or at-home administration¹
• AJOVY expands access across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults¹
• This approval marks an important step in expanding the impact of AJOVY beyond adults since its U.S. approval in 2018, and underscores Teva’s ongoing efforts to advance and address neurological challenges²
  

PARSIPPANY, N.J. and TEL AVIV, Israel, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. With this approval, AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults, marking a meaningful advancement in expanding preventive treatment options for those living with migraine.

Preventative treatment can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day. AJOVY is administered once a month and available for in-office or at home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families.¹

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” said Chris Fox, Executive Vice President, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva. “With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”

1 in 10 children and adolescents in the U.S. suffer from migraine, one of the most common and disabling neurological conditions.³ Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.⁴

"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," said Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute. “Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”

Building on its established success in adult patients since its U.S. approval in 2018, this expanded indication strengthens Teva’s commitment to broadening access to neuroscience therapies across age groups.² AJOVY continues to demonstrate efficacy in addressing the underlying biology of migraine and now provides a treatment pathway for a patient population with historically limited preventive options.

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.⁵ Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.³

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 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 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) 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 second 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. AJOVY (fremanezumab-vfrm) injection, for subcutaneous use. Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
2. Data on file. 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. 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
5. 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).
   

Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com

Teva Investor Relations Inquires
TevaIR@Tevapharm.com

FAQ

What is the new FDA approval for Teva's AJOVY (TEVA)?

The FDA has approved AJOVY for preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45kg or more, making it the first CGRP antagonist approved for pediatric migraine prevention.

What makes AJOVY unique in the pediatric migraine market?

AJOVY is the first and only CGRP antagonist approved for both pediatric episodic migraine prevention and migraine prevention in adults, offering a monthly dosing option with flexibility for in-office or at-home administration.

How common is migraine among children in the US?

1 in 10 children and adolescents in the U.S. suffer from migraine, making it one of the most common and disabling neurological conditions affecting young patients.

What are the administration options for AJOVY in pediatric patients?

AJOVY is administered once monthly and can be given either in-office or at home, providing flexibility to support treatment adherence and reduce burden for families.

What is the weight requirement for pediatric patients to receive AJOVY?

Pediatric patients must weigh 45 kilograms (99 pounds) or more to be eligible for AJOVY treatment.