FDA approves fremanezumab-vfrm for migraine prevention in children aged 6 years, older

FDA approves fremanezumab-vfrm for migraine prevention in children aged 6 years, older | Image credit: Contemporary Pediatrics

On August 5, 2025, the FDA approved fremanezumab‑vfrm (Ajovy; Teva Pharmaceuticals) injection for the preventive treatment of episodic migraine in pediatric patients age 6 years and older who weigh at least 45 kg (99 lb). This marks the first approval of a calcitonin gene‑related peptide (CGRP) ligand for migraine prevention in pediatrics, according to the FDA.¹

Fremanezumab‑vfrm is administered as a 225 mg subcutaneous injection once a month, previously approved in 2018 for adults. The pediatric safety profile was generally consistent with that seen in adult trials. The most frequent side effects included injection site reactions—such as pain, redness, and itching—while serious adverse events like rash, pruritus, and drug hypersensitivity were noted but infrequent.

Migraine is a disabling and common neurological disorder among children and adolescents. The FDA’s approval reflects an effort to expand evidence-based preventive care options for pediatric migraine, a condition that can disrupt school attendance, academic performance, and emotional well-being. With this decision, fremanezumab‑vfrm becomes the only CGRP-targeted therapy in the United States approved for both adolescents and adults.

On April 7, 2025, the FDA accepted a supplemental biologics license application for fremanezumab‑vfrm to include pediatric patients. That filing was supported by phase 3 data from the SPACE trial, which enrolled 237 pediatric patients and demonstrated significant reductions in monthly migraine days compared to placebo, along with a tolerability profile matching that seen in adult studies.²

"The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease,” said Eric A. Hughes, MD, PhD, executive vice president, Global R&D and chief medical officer, at Teva Pharmaceuticals, at the time of data publication. "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."³

Migraine 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, and the availability of fremanezumab‑vfrm aims to fill a significant treatment gap.²

The treatment is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema. Injection site reactions remain the most commonly reported adverse event (≥ 5%).^1,2

References:

1. FDA Approves Drug for the Preventive Treatment of Episodic Migraine in Children Ages 6 Years and Older Who Weigh 45 kg or More. FDA. Press release. August 5, 2025. Accessed August 5, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3eca033
2. Fitch J. FDA accepts sBLA to expand fremanezumab-vfrm indication for episodic migraines in children. Contemporary Pediatrics. April 7, 2025. Accessed August 5, 2025. https://www.contemporarypediatrics.com/view/fda-accepts-sbla-to-expand-fremanezumab-vfrm-indication
3. Teva announces first phase 3 evidence of efficacy and safety of an anti-CGRP monoclonal antibody in children in AJOVY (fremanezumab) SPACE trial for prevention of episodic migraine. Teva Pharmaceuticals. Press release. July 18, 2024. Accessed August 5 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Announces-First-Phase-3-Evidence-of-Efficacy-and-Safety-of-an-Anti-CGRP-Monoclonal-Antibody-in-Children-in-AJOVY-fremanezumab-SPACE-Trial-for-Prevention-of-Episodic-Migraine/default.aspx