Fremenazumab Label Expanded for Treatment of Episodic Migraine in Children Aged 6 to 17 Years

The FDA has approved a label expansion for fremanezumab-vfrm (Ajovy), adding an indication for preventive treatment of episodic migraine in children and adolescents aged 6 to 17 years who weigh at least 45 kilograms (99 pounds).1

According to today's announcement from fremenezumab developer Teva, the approval makes the medication the first calcitonin gene-related peptide (CGRP) antagonist indicated for both pediatric episodic migraine prevention and adult migraine prevention in the US. Fremanezumab is administered once monthly via a 225 mg/1.5 mL single-dose injection, either in-office or at home.1

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” Chris Fox, Teva executive vice president, US commercial and innovative franchise lead and head of global marketing business, said in the announcement. The approval addresses a long-standing treatment gap in the pediatric population, she added, and offers "families added support as they navigate the challenges of this condition.”1

Phase 3 SPACE Clinical Trial

The expanded pediatric indication for fremanezumab was supported by data from the phase 3 SPACE study (NCT03539393), a randomized, double-blind, placebo-controlled, parallel-group trial involving children and young teens with a history of fewer than 14 headache days per month. The study enrolled 237 participants aged 6 to 17 years and demonstrated that fremanezumab significantly reduced migraine frequency over a 12-week period compared with placebo, while maintaining a safety profile consistent with previous findings.2,3

Participants in SPACE were stratified into 2 age groups: 6–11 years and 12–17 years. At study completion, fremanezumab-treated patients showed a greater mean reduction in monthly migraine days (–2.5) compared with those receiving placebo (–1.4; P =.021). Monthly headache days (MHDs) were also significantly reduced with fremanezumab (–2.6) vs placebo (–1.5; P =.017). A higher proportion of patients treated with fremanezumab achieved at least a 50% reduction in monthly migraine days (47.2%) compared with placebo (27.0%; P = .002). The benefits were consistent across the 2 age groups and between sexes, according to the study.2,3

Fremanezumab was generally well tolerated among the young SPACE participants. Adverse events (AEs) were reported in 55% of those receiving fremanezumab and 49% of those in the placebo arm. receiving placebo. The incidence of serious AEs and treatment discontinuations due to AEs was low, occurring in fewer than 3% and 1% of patients, respectively.2,3 The medication's no-loading-dose treatment pathway may help reduce treatment burden and improve adherence for families.

One in 10 children and adolescents in the US experience migraine known as one of the most common and disabling neurologic conditions.4 Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.4

Fremenazumab was originally approved in 2018 for preventive treatment of migraine in adults with dosing options of 225 mg monthly or 675 mg quarterly.

For full prescribing information, clinicians can visit: https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf

References

1. FDA approves expanded indication for AJOVY® (fremanezumab-vfrm), the first anti-CGRP preventive treatment for pediatric episodic migraine. News release. Teva. August 6, 2025. Accessed August 6, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/FDA-Approves-Expanded-Indication-for-AJOVY-fremanezumab-vfrm-The-First-Anti-CGRP-Preventive-Treatment-for-Pediatric-Episodic-Migraine/default.aspx

2. Hershey AD, Szperka CL, Barbanti P, et al. Efficacy and safety of fremanezumab for the preventive treatment of episodic migraine in children and adolescents: a phase 3, randomized, double-blind, placebo-controlled study(PL5.001). Neurology. 2025;104(7_suppl 1). doi:10.1212/WNL.0000000000211143

3. 2.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. News release. Teva Pharmaceuticals. December 4, 2024. Accessed August 6, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/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/default.aspx

4. Al Khalili Y, Asuncion RMD, Chopra P. Migraine headache in childhood. In: Stat Pearls. StatPearls Publishing. Updated March 4, 2023. Accessed August 6, 2025. https://pubmed.ncbi.nlm.nih.gov/32491745/