FDA Approves Fremanezumab as First Anti-CGRP Drug for Prevention of Pediatric Episodic Migraine

The FDA approved fremanezumab-vfrm (Ajovy) for the preventative treatment of episodic migraine for patients aged 6 to 17 years who weigh 45 kg or more. This marks the first approval for a calcitonin gene-related peptide antagonist for the prevention of episodic migraine for pediatric and adult patients.¹

Fremanezumab-vfrm (Ajovy) receives FDA approval for the prevention of episodic migraine for patients aged 6 to 17 years. | Image Credit: BillionPhotos.com - stock.adobe.com

“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, US commercial and innovative franchise lead and head of global marketing business at Teva, said in a news release.¹ “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.”

In a phase 3 study (NCT04458857), investigators compared the efficacy of the drug to the placebo as preventative treatment of episodic migraine. Further, they aimed to evaluate the safety and tolerability of fremanezumab as well as the immunogenicity of the drug. Patients received 1 of 3 treatments: fremanezumab dose A, fremanezumab dose B, or the placebo, all administered subcutaneously. The primary end point was the mean change from baseline in the monthly average number of migraine days during the 12-week period after the first dose of the drug.

Secondary outcomes included the number of individuals with treatment-emergent adverse events, the number of patients with a shift from baseline to last assessment in electrocardiogram findings, the number of patients with any 1 or more clinically significant abnormal vital signs, and the mean change from baseline in the monthly average number of headache days of at least moderate severity during the first 12 weeks of the study.²

In the study, there were 234 patients aged 6 to 17 years included in the study, with 123 receiving the study drug and 111 receiving the placebo. Investigators found that fremanezumab reduced monthly migraine days by 2.5 compared with the placebo at 1.4 over 3 months, and the least square mean change from baseline supported fremanezumab over the placebo in all subgroups stratified by age and sex. For monthly headache days, fremanezumab also showed greater reductions at 2.6 compared with 1.5 for the placebo, with a response rate of 47.2% and 27%, respectively. As for adverse events, the proportion of at least 1 or more AEs was similar between treatment groups at 55% and 49%, respectively.³

"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," Jennifer McVige, MD, MA, pediatric neurologist at the DENT Neurologic Institute, said in a news release.¹ “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.”

READ MORE: Headache and Migraine Resource Center

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REFERENCES

1. FDA approves expanded indication for Ajovy (fremanezumab-vfrm), the first anti-CGRP preventive treatment for pediatric episodic migraine. News release. Teva. August 6, 2025. Accessed August 6, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/FDA-Approves-Expanded-Indication-for-AJOVY-fremanezumab-vfrm-The-First-Anti-CGRP-Preventive-Treatment-for-Pediatric-Episodic-Migraine/default.aspx

2. A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age. ClinicalTrials.gov identification: NCT04458857. Updated June 22, 2025. Accessed August 6, 2025. https://clinicaltrials.gov/study/NCT04458857

3. Hershey AD, Szperka CL, Barbanti P, Pozo-Rosich P, et al. Efficacy and safety of fremanezumab for the preventive treatment of episodic migraine in children and adolescents: a phase 3, randomized, double-blind, placebo-controlled study (PL5.001). Neurology. April 2025. doi:https://doi.org/10.1212/WNL.0000000000211143