- AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in pediatric patients aged 6-17 years
- Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
- Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented positive data from its Phase 3 SPACE study evaluating the efficacy and safety of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favourable safety profile consistent with that observed in the adult population.
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.
One of the lead investigators of the trial, 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 pediatric 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
Fremanezumab also demonstrated a favourable safety profile, and was well tolerated with no safety signals:
- Proportion of children reporting ≥1 adverse events (AEs) was similar between the treatment group vs placebo (55% vs 49%)
- Proportion of patients with serious adverse events (SAEs) and AEs leading to treatment discontinuation was low at ≤3% and ≤1% respectively
“Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licenced treatments to manage this debilitating condition in children.” said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals. “We’ve already seen the benefits of AJOVYin adultsand the SPACE trial has confirmed that children with episodic migraine can also benefit from AJOVY. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden.”
Teva continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.
