Teva Pharmaceuticals’ AJOVY Achieves Primary End Point in Pediatric Phase 3 Migraine Study

19 July 2024 | Friday | News

Teva Pharmaceuticals Industries Ltd. (NYSE and TASE: TEVA) announced positive topline results from its Phase 3 SPACE study, demonstrating AJOVY's (fremanezumab) significant efficacy in reducing Monthly Migraine Days in children and adolescents aged 6-17 years compared to placebo. The safety profile was consistent with adult studies, with full data to be presented later this year.
Public Source | Public Domain

Public Source | Public Domain

  • SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo
  • Efficacy is consistent with AJOVY (fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
  • Full data to be presented at a medical meeting later in 2024
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced  positive topline results from its Phase 3 SPACE study evaluating the efficacy of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. Safety data was consistent with that observed in adult populations, with no emergent safety signals. Full data from the SPACE study will be presented at a medical meeting later this year.

"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,” said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, at Teva Pharmaceuticals. "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. I am pleased to see that AJOVY is continuing to demonstrate its efficacy and safety in different migraine populations, including pediatric patients.”

The SPACE data are the first Phase 3 trial evidence of safety and efficacy of an anti-CGRP monoclonal antibody for the treatment of migraine in a pediatric population. The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations. Teva continues to study the impact of AJOVY(fremanezumab) in pediatric patients with chronic migraine.

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 to approximately 15% among adolescents.1 Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.1

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