FDA Approves Ajovy® for Pediatric Migraine Prevention: A Milestone in Treatment Options for Children Aged 6 to 17

FDA Approves AJOVY® for Pediatric Migraine Prevention: A Game-Changer for Young Patients

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved AJOVY® (fremanezumab-vfrm) for the preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years who weigh at least 45 kg. This makes AJOVY the first and only calcitonin gene-related peptide (CGRP) antagonist approved for this age group, marking a significant advancement in the management of migraines among children and adolescents.

Migraine is a prevalent yet often overlooked condition, affecting approximately 1 in 10 children and adolescents in the United States. The debilitating nature of migraines can lead to missed school days, hinder academic performance, and disrupt social interactions. With AJOVY now available, families have a new tool to help manage this challenging condition.

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” said Chris Fox, Executive Vice President at Teva. “With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and providing families with much-needed support.”

AJOVY is designed to be administered once a month, either in a healthcare setting or at home, making it a convenient option for families. This ease of use is intended to enhance adherence to treatment and reduce the burden on both patients and caregivers.

Dr. Jennifer McVige, a Pediatric Neurologist at the DENT Neurologic Institute, emphasized the importance of this approval: “Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being. Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment that can help reduce the frequency of attacks in younger patients.”

Building on its success in adult patients since its approval in 2018, AJOVY’s expanded indication underscores Teva’s commitment to enhancing access to neuroscience therapies across all age groups. The treatment addresses the underlying biology of migraine, offering a pathway for a patient population that has historically faced limited preventive options.

Understanding Migraine

Migraine attacks can cause severe pain, nausea, vomiting, and heightened sensitivity to light and sound, significantly impairing daily activities. The impact on children and adolescents can be profound, leading to educational challenges and social isolation.

About AJOVY

AJOVY is indicated for the preventive treatment of migraine in adults and episodic migraine in children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more. It is available as a 225 mg/1.5 mL single-dose injection in a pre-filled autoinjector or syringe, with no starting dose required to initiate treatment.

With the FDA’s approval of AJOVY, families now have a promising new option to help manage pediatric migraines, paving the way for improved quality of life for young patients.