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.