FDA Expands Approval of AJOVY as First Anti-CGRP Preventive for Pediatric Episodic Migraine

In a significant development for pediatric migraine care, Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for AJOVY (fremanezumab-vfrm), making it the first and only CGRP (calcitonin gene-related peptide) antagonist approved for the preventive treatment of episodic migraine in children and adolescents aged 6–17 years who weigh at least 45 kilograms (99 pounds).

The approval marks a key milestone in the management of migraine, offering younger patients a targeted preventive option where few have existed before. AJOVY is already approved for use in adults and is administered once monthly, either at home or in a clinical setting—an approach designed to ease treatment adherence and reduce burden on families.

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents,” said Chris Fox, Executive Vice President at Teva. “This FDA approval addresses a long-standing gap in care and offers families added support as they navigate the challenges of this condition.”

Migraine affects approximately 1 in 10 children and adolescents in the U.S., yet it often goes underrecognized and undertreated. The condition can lead to missed school days, difficulty with academic performance, and social withdrawal.

Dr. Jennifer McVige, a pediatric neurologist at the DENT Neurologic Institute, emphasized the clinical importance of the approval: “Pediatric migraine is a complex condition that can significantly impact a child’s life. Having an FDA-approved treatment like AJOVY provides a much-needed preventive option to help reduce the frequency of attacks.”

Since its initial FDA approval for adults in 2018, AJOVY has proven effective in targeting the underlying biology of migraine. Teva’s expanded indication reflects its broader commitment to advancing neuroscience therapies across age groups.

With this approval, AJOVY now stands as a key option in helping children and adolescents better manage episodic migraine, bringing hope and relief to families facing the challenges of this chronic neurological condition.