AJOVY Becomes First CGRP Antagonist Approved for Pediatric Migraine Prevention Following Positive SPACE Trial Results
Key Insights
AJOVY (fremanezumab) achieved FDA approval in August 2025 for preventing episodic migraine (search) in children and adolescents aged 6-17 years weighing 45 kg or more, making it the first CGRP antagonist indicated for both pediatric and adult migraine (search) prevention.
The pivotal SPACE trial demonstrated that AJOVY significantly reduced monthly migraine (search) days by 2.5 days compared to 1.4 days with placebo, with 47.2% of patients achieving a ≥50% reduction in monthly migraine days versus 27.0% with placebo.
Real-world evidence from the PEARL study reinforced AJOVY's long-term effectiveness over 24 months in adults, with over 66% of episodic migraine (search) patients and 51.6% of chronic migraine (search) patients achieving ≥50% reduction in monthly migraine (search) days during the first 6 months.
Teva Pharmaceuticals has achieved a significant milestone in migraine (search) prevention with AJOVY (fremanezumab-vfrm) becoming the first and only calcitonin gene-related peptide (CGRP) antagonist approved for both pediatric and adult patients. The FDA approved AJOVY in August 2025 for the preventive treatment of episodic migraine (search) in children and adolescents aged 6-17 years who weigh 45 kilograms or more, expanding its indication beyond its initial adult approval.
The approval was supported by pivotal Phase 3 data from the SPACE trial, recently published in the New England Journal of Medicine, which demonstrated AJOVY's efficacy and safety in pediatric patients with episodic migraine (search). The 3-month, randomized, placebo-controlled study enrolled 237 children and adolescents aged 6-17 years with episodic migraine.
SPACE Trial Delivers Strong Efficacy Results
In the SPACE trial, AJOVY demonstrated statistically significant reductions in migraine (search) frequency compared to placebo. The treatment reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo, representing a difference of 1.1 days (P = 0.02). Similarly, monthly headache days of at least moderate severity were reduced by 2.6 days versus 1.5 days with placebo (difference: 1.1 days; P = 0.02).
A notably higher proportion of participants achieved clinically meaningful improvement, with 47.2% of AJOVY-treated patients experiencing a ≥50% reduction in MMD compared to 27.0% of placebo patients (P = 0.002). The safety profile remained consistent with that observed in adult studies, with no new safety signals identified.
"The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine (search) in youth, giving physicians critical evidence to guide care for this underserved population," said Andrew D. Hershey, M.D., Ph.D., the study's lead author and Endowed Chair and Director of Neurology at Cincinnati Children's Hospital Medical Center.
Real-World Evidence Supports Long-Term Effectiveness
Complementing the pediatric approval, final analysis from Teva's PEARL real-world study, presented at the European Headache Congress (EHC 2025) in Lisbon, reinforced AJOVY's long-term effectiveness in adult patients. The 24-month observational study assessed 1,140 patients with chronic or episodic migraine (search) across Europe.
The PEARL study met its primary endpoint, with over 66% of patients with episodic migraine (search) and 51.6% with chronic migraine (search) achieving a ≥50% reduction in Monthly Migraine (search) Days during the first 6 months of treatment. Participants benefited from sustained migraine prevention over the full 24-month study period, with injection adherence rates remaining high at approximately 90% and over 75% of participants completing the study duration.
"PEARL has consistently demonstrated the real-world benefits of migraine (search) prevention with fremanezumab in patients suffering from episodic and chronic migraines," said Isabel Pavão Martins, Professor of Neurology at the Faculty of Medicine, University of Lisbon. "The findings underscore the sustained effectiveness, strong treatment adherence, and persistence over a two-year follow-up period, reinforcing its clinical value for migraine prevention."
Safety Profile Remains Consistent Across Populations
Safety analysis from the PEARL study showed that 56.3% of participants reported ≥1 adverse effect, while drug-related serious adverse events were infrequent, occurring in only 0.4% of participants. This demonstrated the long-term safety and tolerability of fremanezumab over the extended study period.
"All enrolled participants were included in the safety analysis of fremanezumab, and the results further strengthen the evidence supporting its long-term safety and tolerability," said Dr Gürdal Sahin from the Department of Clinical Sciences, Lund University, Skåneuro Neurology Clinic, Lund, Sweden.
Addressing Critical Unmet Need in Pediatric Population
The approval addresses a significant unmet medical need, as an estimated 1 in 10 children and adolescents in the U.S. live with migraine (search). The condition can cause significant disability in young patients, leading to absence from school, impaired educational performance, and missed social activities.
"With an estimated 1 in 10 children and adolescents in the U.S. living with migraine (search), 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. "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."
AJOVY is administered as monthly subcutaneous injections, with dosing based on patient weight: 120 mg for those weighing less than 45 kg and 225 mg for those weighing 45 kg or more. The treatment can be administered by a healthcare professional or at home by patients 13 years of age or older or their caregivers, with no starting dose required to begin treatment.