FDA Approves Fremanezumab as First Anti-CGRP Preventive Therapy for Pediatric Episodic Migraine

Chris Fox

The FDA has approved an expanded indication for Teva’s fremanezumab (Ajovy) to include the preventive treatment of pediatric patients with episodic migraine aged 6-17 who weigh 45 kilograms or more. With the approval, fremanezumab becomes the first anti-calcitonin gene-related peptide (CGRP)-targeting treatment approved for both pediatric episodic migraine prevention and migraine prevention in adults.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, executive vice president, U.S. Commercial and Innovative Franchise Lead, and head of Global Marketing Business at Teva, said in a statement.¹ "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."

The expanded indication into pediatrics was based on data from the phase 3 SPACE study (NCT03539393), a double-blind, placebo-controlled, parallel-group study of pediatric patients with history of less than 14 headache days a month. SPACE, which comprised 237 pediatric patients aged 6-17, showed that fremanezumab treatment resulted in statistically significant superior efficacy over a 12-week period compared with placebo, while maintaining a safety profile that was consistent with prior observations.

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In SPACE, patients were subgrouped by age, into categories of 6-11 years and 12-17 years. At the conclusion of the study, investigators found a significant reduction in monthly migraine days in fremanezumab-treated patients (–2.5) vs placebo (–1.4; P = .0210) as well as a significant reduction in monthly headache days (MHD; –2.6 vs –1.5; P = .0172). Notably, a higher proportion of patients in SPACE achieved at least a 50% response on fremanezumab vs placebo (47.2% vs 27.0%; P = .0016), with benefits that were similar across both subgroups and between boys and girls.²

"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," Jennifer McVige, MD, MA, pediatric neurologist at the DENT Neurologic Institute, said in a statement.¹ "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."

Approved originally in 2018, fremanezumab is administered as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. In its original indication, the medication came in 2 dosing options: monthly (225 mg) or quarterly (675 mg) subcutaneous injections. It remains contraindicated for patients with serious hypersensitivity to fremanezumab or to any of the excipients.

In SPACE, fremanezumab was considered well tolerated, with a similar proportion of patients reporting at least 1 adverse event relative to placebo (55% vs 49%). In addition, the number of patients with serious AEs and AEs that led to treatment discontinuation was low, at around less than 3% and 1%, respectively. Fremanezumab comes with notable safety information in its labeling, including caution about hypersensitivity reactions, development of hypertension, and the occurrence of Raynaud’s phenomenon.

REFERENCES
1. FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. News release. Teva Pharmaceuticals. August 6, 2025. Accessed August 6, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/
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. 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