The U.S. Food and Drug Administration (FDA) has officially approved Ajovy (fremanezumab-vfrm), a single-dose injection, for the preventive treatment of episodic migraines in children and adolescents.
This approval marks a significant advancement in managing a condition affecting approximately one in ten young individuals in the United States.
Migraine in children and teens is frequently underdiagnosed and undertreated, despite its profound impact on academic performance, school attendance, and social interactions.
Ajovy is the first and only calcitonin gene-related peptide (CGRP) antagonist sanctioned for migraine prevention in pediatric patients as well as adults.
Approved for use in patients aged 6 to 17 years who weigh at least 45 kilograms (99 pounds), Ajovy is administered as a 225-mg/1.5-mL injection via a prefilled autoinjector or syringe. The medication can be given by a healthcare professional or self-administered at home, including by parents or caregivers.
“Pediatric migraine is a complex condition that can significantly disrupt daily life, affecting everything from school performance to emotional health,” said Dr. Jennifer McVige of the DENT Neurologic Institute in Buffalo, New York. “The FDA approval of Ajovy provides a targeted preventive treatment option, helping reduce migraine frequency in younger patients and offering clinicians a valuable tool to address this often overlooked disorder.”
Teva Pharmaceuticals holds the approval for marketing Ajovy for this expanded pediatric indication.
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