FDA Approves Ajovy for Migraine Prevention in Children and Teens

By Lori Solomon HealthDay Reporter

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 11, 2025.

via HealthDay

MONDAY, Aug. 11, 2025 -- The U.S. Food and Drug Administration has approved the single-dose Ajovy (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents.

In the United States, one in 10 children and adolescents experience migraine, a common but often underrecognized and undertreated condition that can cause missed school, academic challenges, and social disruptions.

Ajovy is the first and only calcitonin gene-related peptide antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults. Ajovy is authorized for adults and children/adolescents aged 6 to 17 years and weighing at least 45 kg (99 lb). Ajovy is a 225-mg/1.5-mL single-dose injection, available in a prefilled autoinjector or syringe, and can be given by a health care professional or self-administered or administered by a parent or caregiver in the home environment.

"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," Jennifer McVige, M.D., from the DENT Neurologic Institute in Buffalo, New York, said in a statement. "Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition."

Approval of Ajovy was granted to Teva Pharmaceuticals.

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Source: HealthDay

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