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New data on fremanezumab (AJOVY®) show that it significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in paediatric patients aged 6-17.
This efficacy was consistent with Fremantumab pivotal Phase 3 and Real-World Evidence studies in adults, and no new emergent safety signals were observed.
The data was presented as a late-breaker at the recent European Headache Congress (EHC) in Rotterdam, Netherlands. It was part of the Phase 3 SPACE study evaluating the efficacy and safety of fremanezumab for the prevention of episodic migraine in children and adolescent patients aged 6-17.
Migraine can cause significant disability in children
Migraine is common among children, with an overall estimated prevalence of 7.7%. The prevalence increases from 5% among children aged 5 to 10 years old to approximately 15% among adolescents. Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.
Presenting the data, Professor Patricia Pozo-Rosich, Headache Unit and Research Group, Head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute, Barcelona said “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 favourable safety and tolerability for the prevention of episodic migraine in children and adolescents.”
SPACE is a multicentre, double-blind study evaluating the efficacy and safety of fremanezumab in 237 children and adolescents with episodic migraine aged 6-17 years. The paediatric study participants had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days a month. The trial included subgroup analyses by age (6 -11 years and 12 -17 years) and by sex.
Highlights from the SPACE data showed that over 3 months fremanezumab achieved:
- Significant reduction in monthly migraine days (MMD) vs placebo (-2.5 vs -1.4; p=0.0210)
- Significant reduction in monthly headache days (MHD) vs placebo (-2.6 vs -1.5; p=0.0172)
- Significantly higher number of children achieving a 50% response rate vs placebo (47.2% vs 27.0%; p=0.0016)
- Benefits were similar in both the age subgroups and between boys and girls
“Migraine has a severe impact on young people living with this condition. There is an unmet need for migraine care for children and young people,” said Dr Makarand Bagul, Senior Medical and Technical Director, Teva UK & Ireland. “This is potentially a significant step forward for the care of migraine in children and adolescents who are having to live with this burden.”
