Teva Reports Positive Phase 3 Results for AJOVY® in Preventing Episodic Migraine in Youth

Teva Pharmaceutical Industries Ltd. has unveiled promising results from its Phase 3 SPACE study, which assesses the efficacy and safety of AJOVY® (fremanezumab) for preventing episodic migraines in children and adolescents aged 6-17 years. The trial demonstrated a significant reduction in monthly migraine days (MMD) and monthly headache days (MHD) compared to a placebo over a 12-week period, with a safety profile consistent with studies conducted in adults.

Migraines affect a considerable number of children, with an overall prevalence estimated at 7.7%. Specifically, the prevalence increases from approximately 5% in children aged between 5 to 10 years to around 15% among adolescents. The condition can lead to significant disability, affecting school attendance, educational performance, and social activities for young patients.

Professor Patricia Pozo-Rosich, a lead investigator in the trial, emphasized the importance of this milestone for clinicians and young patients. She stated that the Phase 3 trial of a CGRP-pathway treatment, fremanezumab, has shown significant efficacy and favorable tolerability for preventing episodic migraines in this age group, providing a much-needed treatment option.

The SPACE study was a multicenter, double-blind trial that included 237 pediatric participants diagnosed with migraines for at least six months and experiencing fewer than 14 headache days per month. The study also featured subgroup analyses by age (6-11 years and 12-17 years) and by sex.

Key findings from the SPACE study indicated that over three months, fremanezumab significantly reduced monthly migraine days compared to placebo (-2.5 vs. -1.4; p=0.0210) and monthly headache days (-2.6 vs. -1.5; p=0.0172). Additionally, a significantly higher number of children achieved a 50% reduction in migraine days compared to the placebo group (47.2% vs. 27.0%; p=0.0016). These benefits were consistent across age groups and sexes.

Moreover, fremanezumab displayed a favorable safety profile, with the proportion of children reporting at least one adverse event being similar between the treatment and placebo groups (55% vs. 49%). The incidence of serious adverse events (SAEs) and adverse events leading to treatment discontinuation was low, at 3% and 1%, respectively.

Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva Pharmaceuticals, noted the rising incidence of childhood migraines over the past three decades and the limited innovation in licensed treatments. He highlighted the significance of the SPACE trial in demonstrating that children with episodic migraine can benefit from AJOVY, marking a considerable advancement in the care of pediatric patients with migraines.

Teva continues to research the impact of fremanezumab on pediatric patients with chronic migraines and its long-term safety. AJOVY® is currently indicated for the prophylaxis of migraines in adults with at least four migraine days per month. It is available in single-dose injections, administered either monthly or quarterly, and can be given by healthcare professionals or at home by patients or caregivers.

Teva Pharmaceutical Industries Ltd. is a global leader in the pharmaceutical industry, committed to improving health outcomes through innovative and generic medicines. With a significant global presence, Teva continues to drive scientific innovation and deliver quality medicines to millions of patients worldwide.