Fremanezumab Aims to Become First CGRP-Targeting Migraine Preventive for Pediatric and Adults Following sBLA Acceptance

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Key Takeaways

Fremanezumab's expanded indication targets pediatric migraine prevention, potentially becoming the first CGRP therapy for both adults and children.
The phase 3 SPACE study showed significant efficacy and safety in reducing monthly migraine and headache days in children.
Fremanezumab's initial 2018 approval was based on its efficacy in reducing migraine days in adults, with common adverse events being injection site reactions.

Teva’s migraine therapy fremanezumab (Ajovy) may soon expand its reach to pediatric patients, as the FDA reviews a supplemental application for its use in children and adolescents aged 6 to 17.

Eric Hughes, MD, PhD

According to a new announcement, the FDA has accepted Teva Pharmaceuticals’ supplemental biologics license application (sBLA) for fremanezumab (Ajovy) to expand its indication for the prevention of migraine in pediatric and adolescent patients aged 6-17 years who weigh 45 kilograms or more. If approved, the medication would be the first calcitonin gene-related peptide (CGRP)-targeting therapy on market indicated for the prevention of migraine in both adults and pediatrics.¹

Fremanezumab was originally approved by the FDA in 2018 for the preventive treatment of migraine in adults, becoming one of the first antibodies to target the CGRP pathway, a major development in migraine care. It was approved in 2 dosing options: monthly (225 mg) or quarterly (675 mg) subcutaneous injections. It was considered part of a newer generation of CGRP-targeted therapies, which includes erenumab (Aimovig; Amgen), galcanezumab (Emgality; Eli Lilly), and eptinezumab (Vyepti; Lundbeck).

The sBLA for the pediatric indication was based on findings from the phase 3 SPACE study (NCT03539393), a randomized, double-blind, placebo-controlled, parallel-group trial comprising 237 pediatric patients with migraine aged 6-17 years. Overall, the study showed statistically significant superior efficacy of the medication compared with placebo over a 12-week period with a favorable safety profile that was consistent with what was previously observed in adults.

"Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited," Eric Hughes, MD, PhD, executive vice president, global R&D, and chief medical officer at Teva, said in a statement.¹ "As we work to bring the benefits of Ajovy to younger patients, we build upon its proven success in adults. If approved, Ajovy could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population."

SPACE comprised pediatric patients who had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days a month. The trial included subgroups analyses by age (6-11 years and 12-17 years). Overall, results revealed a significant reduction in monthly migraine days (MMD) vs placebo (–2.5 vs –1.4; P = .0210), and a significant reduction in monthly headache days (MHD; –2.6 vs –1.5; P = .0172). In addition, investigators observed a significantly higher proportion of patients achieving at least a 50% response on fremanezumab vs placebo (47.2% vs 27.0%; P = .0016), with benefits that were similar across both age subgroups and between boys and girls.²

In the study, fremanezumab also demonstrated a favorable safety profile, and was well tolerated with no safety signals. Overall, the proportion of children reporting at least 1 adverse event (AE) was similar between the treatment group vs placebo (55% vs 49%). Furthermore, the number of patients with serious AEs and AEs that led to treatment discontinuation was low, at around less than 3% and 1%, respectively.

Patricia Pozo-Rosich, MD, PhD

In late 2024, when Teva announced positive data from SPACE, one of the lead investigators, Patricia Pozo-Rosich, MD, PhD, director of the Headache and Craniofacial Pain Clinical Unit and the Migraine Adaptive Brain Center at the Vall d’Hebron University Hospital, said in a statement that, "This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them. This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with favorable safety and tolerability for the prevention of episodic migraine in children and adolescents."²

Fremanezumab’s original 2018 approval was based on supporting data from 2 studies in the phase 3 HALO clinical trial program. In these trials, the fully humanized anti-CGRP monoclonal antibody reduced MMDs by at least 50% in roughly 45% of patients with episodic migraine and about 40% of patients with chronic migraine in clinical trials. Across both trials, the most common AEs observed were injection site reactions of pain, induration, and erythema.³