FDA Approves Ajovy for Migraine Prevention in Children and Adolescents

The U.S. Food and Drug Administration (FDA) has granted approval for the use of Ajovy (fremanezumab-vfrm) as a preventive treatment for episodic migraines in children and teenagers. This marks a significant advancement in pediatric migraine management, addressing a common yet often overlooked condition affecting approximately one in ten children and adolescents in the United States. Migraines in young individuals can lead to missed school days, difficulties with learning, and social challenges.

Ajovy is unique as it is the first medication in its class—a calcitonin gene-related peptide (CGRP) antagonist—approved for both pediatric and adult patients. It is suitable for children and teens aged 6 to 17 years who weigh at least 45 kilograms (99 pounds). The medication comes in a 225-mg/1.5-mL single-dose injection, which can be administered by healthcare professionals or self-injected at home by the patient or a caregiver using a prefilled autoinjector or syringe.

Jennifer McVige, M.D., from the DENT Neurologic Institute in Buffalo, New York, emphasized the impact of migraines on young patients, noting that an approved treatment offers new hope. She explained, "Pediatric migraine is a complex condition that can significantly influence a child's daily life, from school performance to emotional well-being. Having an FDA-approved option like Ajovy provides a targeted approach to prevention, helping to reduce migraine frequency and improve quality of life."

The approval was granted to Teva Pharmaceuticals, reflecting the company's commitment to expanding migraine treatment options.

More details about this approval can be found in the official announcement from Teva.

Source: https://medicalxpress.com/news/2025-08-fda-ajovy-migraine-children-teens.html