AJOVY (fremanezumab-vfrm) shows significant reduction in monthly migraine days in children and adolescents in the Phase 3 SPACE trial, supporting its FDA-approved role as a preventive treatment for pediatric episodic migraine.
Written By: Nikita Chaudhari, BPharm
Reviewed By: Pharmacally Editorial Team
Teva Pharmaceuticals today reported detailed results from the Phase 3 SPACE trial showing that AJOVY (fremanezumab-vfrm) significantly reduced migraine burden in children and adolescents with episodic migraine. These findings were published in the New England Journal of Medicine and build on the U.S. Food and Drug Administration’s expanded approval of AJOVY for pediatric episodic migraine prevention in patients aged 6 to 17 who weigh at least 45 kg.
Eric Hughes, M.D., Ph.D., Executive Vice President of Global R&D and Chief Medical Officer at Teva, emphasized that migraine affects about one in ten children and adolescents in the U.S., creating a serious need for effective preventive treatments. He noted that the SPACE trial results published in the New England Journal of Medicine strengthen the evidence for AJOVY and expand on its well-established benefits in adults, reflecting Teva’s commitment to innovation for the migraine community.
Clinical Evidence
In the randomized, double-blind, placebo-controlled SPACE trial (NCT04458857), 237 children and adolescents aged 6 to 17 years with episodic migraine received monthly subcutaneous injections of AJOVY or placebo over 12 weeks. The trial’s primary goal was to compare changes in monthly migraine days between groups. Patients in the AJOVY arm experienced a reduction of 2.5 monthly migraine days compared with a 1.4-day reduction in the placebo group, yielding a statistically significant difference. Monthly headache days of at least moderate severity also fell more with AJOVY (2.6 days versus 1.5 days). A larger share of participants treated with AJOVY (47.2 %) achieved at least a 50 % reduction in monthly migraine days compared with those receiving placebo (27.0 %).
Safety findings were consistent with previous studies. There was no new safety signals identified in the pediatric population, and the overall profile aligned with what has been seen in adult patients. Common adverse events in trials of CGRP inhibitors typically include injection-site reactions, which were generally mild.
About AJOVY
AJOVY works by blocking the calcitonin gene-related peptide (CGRP) pathway, a key contributor to migraine pathophysiology. CGRP antagonists have already proven effective in adult migraine prevention, and the SPACE data confirm a similar benefit in younger patients.
Andrew D. Hershey, M.D., Ph.D., lead author of the study and Director of Neurology at Cincinnati Children’s Hospital Medical Center, highlighted that preventing migraine attacks is essential for healthy development, school participation, and social wellbeing. He added that the SPACE trial confirms a CGRP-targeted therapy like AJOVY can meaningfully reduce migraine frequency in young patients and provide physicians with much-needed guidance for this underserved population.
The U.S. Food and Drug Administration approved AJOVY in August 2025 for the preventive treatment of episodic migraine in children and adolescents aged 6 to 17 years who weigh at least 45 kilograms, expanding its earlier approval for adults. This milestone offers a much-needed option for young patients, as migraine during childhood and adolescence often interferes with school attendance, social engagement, and overall quality of life.
References
AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine, 14 January 2026, Teva Pharmaceutical Industries Ltd. – AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine
Andrew D. Hershey et al, Fremanezumab in Children and Adolescents with Episodic Migraine, N Engl J Med 2026;394:243-252, DOI: 10.1056/NEJMoa2504546, https://www.nejm.org/doi/full/10.1056/NEJMoa2504546
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age, ClinicalTrials.gov ID NCT04458857, https://clinicaltrials.gov/study/NCT04458857