FDA Approves Fremanezumab to Prevent Episodic Migraine in Children

Teva Pharmaceuticals announced on August 6, 2025, that the US Food and Drug Administration (FDA) approved fremanezumab (AJOVY) for the preventive treatment of episodic migraine in children and adolescents aged 6 – 17 years who weigh ≥ 99 pounds (45 kg).1 Fremanezumab has now become the first calcitonin gene-related peptide (CGRP) antagonist approved for preventive treatment of episodic migraine in pediatric patients.

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

The decision was based on positive data from the phase 3 SPACE trial, showing participants on fremanezumab had significantly reduced monthly migraine days and monthly headache days compared to placebo.1 Fremanezumab also demonstrated a consistent safety profile in children and adolescents compared to the adult population. This approval expands the indication for fremanezumab, previously approved for adults with migraine in 2018.2

Fremanezumab, available as a 225 mg or 1.5 mL single-dose injection in a pre-filled autoinjector or in a pre-filled syringe, can be administered either by a healthcare professional or at home once a month. The medication has no required starting dose.1

Some participants experienced mild to moderate hypersensitivity reactions after fremanezumab, observed within hours or 1 month after administration, and examples included rash, pruritus, drug hypersensitivity, and urticaria.1 There were reports of anaphylaxis, angioedema, hypertension, and Raynaud’s Phenomenon in the post-marketing setting; if these occur, discontinuation may be warranted. In the clinical trials, the most common adverse events were injection site reactions.

“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, US Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva, in the press 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.”

References

1. FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. Teva Pharmaceuticals. August 6, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/. Accessed August 6, 2025.

2. Kunzmann, K. Fremanezumab Becomes Second CGRP Inhibitor Approved for Migraine Prevention. HCPLive. September 14, 2018. https://www.hcplive.com/view/fremanezumab-becomes-second-cgrp-inhibitor-approved-for-migraine-prevention. Accessed August 6, 2025.