FDA Approves Migraine Treatment for Young Patients
AJOVY Expands to Children and Adolescents Ages 6-17
The U.S. Food and Drug Administration (FDA) has greenlit AJOVY® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged 6 to 17 who weigh at least 45 kilograms (99 pounds). This marks a significant expansion for the calcitonin gene-related peptide (CGRP) antagonist, now offering a monthly therapeutic option for younger individuals, a group often underserved by existing treatments.
New Hope for Pediatric Migraine Sufferers
The approval positions AJOVY as the first and only CGRP antagonist indicated for both pediatric episodic migraine prevention and adult migraine prevention. This dual indication addresses a critical unmet need, providing a targeted approach to managing this debilitating neurological condition in a younger demographic.
“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,”
—Chris Fox, Executive Vice President, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva
This regulatory milestone builds upon AJOVY’s initial U.S. approval for adults in 2018. Teva Pharmaceuticals, the developer, emphasizes its commitment to advancing neurological treatments across all age groups. The drug is administered monthly, offering flexibility for in-office or at-home use, which aims to improve patient adherence and ease the burden on families.
Addressing a Widespread Pediatric Concern
Migraine affects approximately 1 in 10 children and adolescents in the United States, frequently leading to missed school days, academic difficulties, and social limitations. Historically, pediatric migraine has been underdiagnosed and undertreated, highlighting the importance of new therapeutic avenues like AJOVY.
“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 for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”
—Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute
Understanding Migraine and AJOVY
Migraine attacks are characterized by debilitating pain, nausea, sensitivity to light and sound, and can severely impair daily functioning. In children and adolescents, this can translate to significant disability, affecting education and social engagement. AJOVY functions by targeting the CGRP pathway, a key mechanism in migraine pathology.
The medication is available as a 225 mg/1.5 mL single-dose injection. It can be administered by a healthcare professional or at home by the patient or a caregiver, with no specific starting dose required. Important safety information includes potential hypersensitivity reactions, new or worsening hypertension, and Raynaud’s phenomenon.
Teva Pharmaceuticals, headquartered in Israel with U.S. operations, is a global leader in innovative and generic medicines. The company’s dedication to improving health is reflected in its broad portfolio and ongoing research in areas such as neuroscience.