Migraine Relief for Kids and Teens: New Drug Shows Promise
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A new treatment option is now available for children and adolescents struggling with migraine, offering hope for reduced pain and fewer missed school days.
- AJOVY (fremanezumab-vfrm) is the first and only calcitonin gene-related peptide (CGRP) antagonist approved to prevent migraine in both children and adults.
- In a recent study, AJOVY significantly reduced monthly migraine and headache days in young patients compared to a placebo.
- The U.S. Food and Drug Administration (FDA) approved AJOVY in August 2025 for use in children and adolescents aged 6-17 who weigh 45 kilograms (99 pounds) or more.
For the first time, children and teenagers experiencing episodic migraine have a targeted preventive treatment option. Results from the pivotal Phase 3 SPACE trial, published in the New England Journal of Medicine, demonstrate that AJOVY significantly reduces the frequency of migraine and headache days in pediatric patients. This is a game-changer for a population where migraine can severely disrupt daily life.
How AJOVY Performed in the SPACE Trial
The SPACE trial enrolled 237 children and adolescents aged 6-17 with episodic migraine. Participants received either monthly subcutaneous injections of fremanezumab (dosage adjusted for weight) or a placebo over a 12-week period. The results were compelling: AJOVY reduced monthly migraine days (MMD) by an average of 2.5 days compared to 1.4 days with the placebo (a difference of 1.1 days; P = 0.02). Similarly, monthly headache days of at least moderate severity were reduced by 2.6 days with AJOVY versus 1.5 days with placebo (a difference of 1.1 days; P = 0.02).
Importantly, the study found no new safety concerns, and the safety profile of AJOVY in young patients was consistent with what has been observed in adult studies.
A Critical Need Addressed
“With an estimated 1 in 10 children and adolescents in the U.S. living with migraine, 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. “The SPACE trial results…add to the growing body of evidence supporting AJOVY and build on its established use in adults.”
Andrew D. Hershey, M.D., Ph.D., lead author of the study and Director of Neurology at Cincinnati Children’s Hospital Medical Center, emphasized the importance of preventing migraine attacks in young people. “Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability and overall social well-being,” he stated. “The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population.”
Understanding Migraine in Children and Adolescents
Migraine attacks can cause debilitating pain, nausea, vomiting, and sensitivity to light and sound, significantly impacting a child’s ability to function. This can lead to school absences, impaired academic performance, and missed social opportunities.
About AJOVY and its Use
AJOVY is indicated for the 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. It is administered as a monthly subcutaneous injection, available in a pre-filled autoinjector or syringe, and can be given by a healthcare professional or a caregiver for patients 13 years or older. Full prescribing information is available here.
Important Safety Information
AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or any of its components. Hypersensitivity reactions, including rash and urticaria, have been reported. Development of hypertension and Raynaud’s phenomenon have also been reported following use of CGRP antagonists. The most common adverse reaction in clinical trials was injection site reactions.
Please click here for the full U.S. Prescribing Information.
