Migraine attacks can cause significant pain accompanied by nausea, vomiting, and sensitivity to light and sound, all of which can severely disturb daily life. In children and adolescents, migraine-related disability can lead to school absences, reduced academic performance, and limited social participation.
AJOVY has been approved by the U.S. Food and Drug Administration (FDA) as a preventive treatment for episodic migraine in children and adolescents aged 6 to 17 years who weigh at least 45 kilograms (99 pounds). It is available as a 225 mg/1.5 mL single-dose injection, offered in both a prefilled autoinjector and a prefilled syringe for convenient administration. AJOVY can be administered by the healthcare provider, or by the patients or caregivers in a home setting. AJOVY does not require a loading dose to initiate therapy.
This approval marks AJOVY as the first and only calcitonin gene-related peptide (CGRP) inhibitor approved for the prevention of episodic migraine in children and adolescents, in addition to its existing indication for the treatment of migraine in adults. This milestone represents a significant advancement in expanding preventive migraine treatment options for pediatric migraine.
Preventive therapy is an important aspect of reducing migraine episodes so that children and adolescents can better integrate migraine management into daily life. AJOVY is a once-monthly injection given in the clinical or home setting to facilitate treatment compliance and reduce the burden on families.
“Migraines are a common but often unseen condition that can seriously disrupt the lives of young people and are often under-treated or mismanaged,” said Chris Fox, Executive Vice President, Teva, and Head of Global Marketing Business. “The FDA approval of AJOVY provides a new treatment for these young patients, addressing a long-standing gap in care and providing families with much-needed support.”
About one in ten children and adolescents in the United States experience migraines, a very common and debilitating neurological disorder. Pediatric migraine is a complex condition that can have a significant impact on a child’s behavior, mental well-being, and academic achievement, according to Dr. Jennifer McVige, the pediatric neurologist at the DENT Neurologic Institute “The availability of an FDA-approved option like AJOVY is an important step forward, providing a new preventive therapy option that is targeted, which can decrease the frequency of migraine episodes in children, and help health-care practitioners to manage with this often underestimated diagnosis.”
Building on its proven efficacy in adults since its U.S. approval in 2018, the pediatric indication supports Teva’s continued commitment to expanding access to neuroscience treatments for patients of all ages. AJOVY targets the biological pathways of migraine and now offers an important preventive option for pediatric patients, a group that has historically had a limited number of treatment choices.
References: Teva Pharmaceuticals. FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. Published August 6, 2025. Accessed August 7, 2025. Teva Pharmaceutical Industries Ltd. – FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine.
