Fremanezumab Shows Positive Results for Pediatric Use in Phase 3 Trial

In July, Teva announced positive results in a phase 3 trial of migraine medication Ajovy (fremanezumab) for children and adolescents, making it the first anti-CGRP (calcitonin gene-related peptide) monoclonal antibody to be effective in this population. 

The SPACE trial included 235 participants between 6 and 17 years of age who were randomly administered subcutaneous fremanezumab or placebo over 12 weeks to prevent episodic migraines. The study met its primary endpoint, with patients receiving fremanezumab experiencing significantly fewer monthly migraine days compared to those who received placebo.

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“The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them," said Teva Chief Medical Officer Eric Hughes in a press release. "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.”

The American Migraine Foundation estimates that 1 in 10 children lives with migraine, however other CGRP antibodies approved in the US are only for adult use, such as erenumab, eptinezumab, and galcanezumab. 

References 
Teva touts first CGRP success in Phase III paediatric migraine prevention study. FirstWord Pharma. News release. July 18, 2024. Accessed August 8, 2024.

Migraine in children. American Migraine Foundation. April 8, 2021. Accessed August 8, 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. Press release. July 18, 2024. Accessed August 8, 2024.