FDA Approves First CGRP Antagonist for Pediatric Migraine Prevention as Ajovy Expands to Children
Key Insights
The FDA has approved Ajovy (fremanezumab-vfrm) for preventive treatment of episodic migraine (search) in children and adolescents aged 6-17 years weighing at least 45 kg, making it the first CGRP antagonist approved for pediatric migraine (search) prevention.
The approval addresses a significant treatment gap for pediatric migraine (search), which affects approximately 1 in 10 children and adolescents in the U.S. and often leads to missed school days and impaired academic performance.
Ajovy is administered as a 225 mg subcutaneous injection once monthly and can be given in-office or at home, with the pediatric safety profile generally consistent with adult trials.
The U.S. Food and Drug Administration has approved Ajovy (fremanezumab-vfrm) for the preventive treatment of episodic migraine (search) in children and adolescents aged 6-17 years who weigh 45 kilograms or more, marking the first calcitonin gene-related peptide (CGRP) antagonist approved for pediatric migraine (search) prevention. Teva Pharmaceuticals announced the approval on August 6, 2025, expanding access to this monthly injectable treatment that was previously available only for adults since 2018.
Addressing Unmet Medical Need in Pediatric Migraine
The approval addresses a critical gap in pediatric migraine (search) care, as approximately 1 in 10 children and adolescents in the U.S. suffer from migraine (search), one of the most common and disabling neurological conditions. Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.
"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, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva. "With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition."
Clinical Evidence and Administration
The approval was supported by phase 3 data from the SPACE trial, which enrolled 237 pediatric patients and demonstrated significant reductions in monthly migraine (search) days compared to placebo. The pediatric safety profile was generally consistent with that seen in adult trials, with injection site reactions being the most frequent side effects, including pain, redness, and itching.
Ajovy is administered as a 225 mg subcutaneous injection once monthly and is available in both pre-filled autoinjector and pre-filled syringe formats. The treatment can be administered by a healthcare professional or at home by a patient or caregiver, with no starting dose required to begin treatment.
Clinical Impact and Expert Perspective
Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute (search), emphasized the clinical significance of this approval: "Pediatric migraine (search) 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 (search) that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition."
Migraine (search) affects an estimated 7.7% of children, with incidence increasing from around 5% in children aged 5 to 10 to approximately 15% in adolescents. Current prevention options for this age group remain limited, making the availability of fremanezumab-vfrm a significant advancement in filling this treatment gap.
Safety Profile and Contraindications
The treatment is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients, as reactions have included anaphylaxis and angioedema. The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.
Additional safety considerations include monitoring for hypertension development or worsening of pre-existing hypertension, as well as potential development of Raynaud's phenomenon, which has been reported in the postmarketing setting following use of CGRP antagonists.
Expanding Treatment Access
This expanded indication strengthens Teva's commitment to broadening access to neuroscience therapies across age groups, building on Ajovy's established success in adult patients. The approval marks an important step in expanding the impact of Ajovy beyond adults and underscores ongoing efforts to advance and address neurological challenges across different patient populations.
Eric A. Hughes, MD, PhD, executive vice president, Global R&D and chief medical officer at Teva Pharmaceuticals, previously noted: "The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine (search) who are greatly impacted by this debilitating disease. The SPACE data supports our ambitions to bring the proven benefits of [fremanezumab-vfrm] to children and adolescent patients who have fewer treatment options available to them."