Reaction and Significance of Fremanezumab’s Expanded Indication in Pediatric Migraine: Patricia Pozo-Rosich, MD, PhD

WATCH TIME: 3 minutes

"For many years, we had no proven treatments for children and teenagers with migraine. Now, with fremanezumab, we finally have a safe and effective option that can truly make a difference."

Fremanezumab (Ajovy; Teva), a fully humanized calcitonin gene-related peptide (CGRP)-targeting monoclonal antibody, was first approved in 2018 as a preventive treatment of migraine in adults, becoming the second marketed CGRP therapy behind erenumab (Aimovig; Amgen). The drug, which comes with a monthly and quarterly dosing option, is administered as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe.

Earlier this month, the FDA greenlit an expanded indication for fremanezumab to include the preventive treatment of pediatric patients with episodic migraine aged 6-17, making it the first CGRP-targeting medication approved for both pediatric and adult migraine prevention. The expanded indication was based on data from SPACE (NCT03539393), a phase 3, double-blind, placebo-controlled trial of 237 pediatric patients with a history of less than 14 headache days per month. All told, the study was considered a success, with those on fremanezumab showing statistically significantly better change in monthly migraine days and monthly headache days vs those on placebo.

In the weeks following the FDA’s decision, NeurologyLive^® sat down with Patricia Pozo-Rosich, MD, PhD, study investigator of SPACE, who gave thoughts on the significance of having a proven therapeutic option for children and adolescents with migraine. Pozo-Rosich, who serves as head of the neurology department at the Vall d’Hebron University Hospital, touched on how previous studies, such as the CHAMP trial, fueled the long-standing perception that placebo effects were too strong to overcome in pediatric populations, leaving clinicians with limited strategies beyond lifestyle interventions or off-label attempts. Furthermore, she emphasized the burden migraine places on teenagers in particular, and stressed the importance of having a safe and effective treatment to help address some of the current unmet needs.

REFERENCES
1. FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. News release. Teva Pharmaceuticals. August 6, 2025. Accessed August 25, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/
2. Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial. News release. Teva Pharmaceuticals. December 4, 2024. August 25, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial/default.aspx