Teva Pharmaceutical Industries announced positive Phase 3 data for fremanezumab (Ajovy) in preventing episodic migraine in children and adolescents aged 6 to 17 years. The SPACE study (NCT04530110) demonstrated statistically significant efficacy compared to placebo over a 12-week treatment period, with a safety profile consistent with that seen in adults.
The multicenter, randomized, placebo-controlled, parallel-group trial evaluated the safety, efficacy, and tolerability of subcutaneous fremanezumab administration versus placebo. The study included 237 pediatric patients diagnosed with migraine for at least six months, experiencing fewer than 14 headache days per month. Participants were divided into age subgroups of 6 to 11 years and 12 to 17 years.
Key Findings from the SPACE Trial
Over the 3-month study period, fremanezumab demonstrated:
- A significant reduction in monthly migraine days (MMD) compared to placebo (-2.5 vs -1.4; P = 0.0210).
- A significant reduction in monthly headache days (MHD) versus placebo (-2.6 vs -1.5; P = 0.0172).
- A significantly higher percentage of children achieving a 50% response rate compared to placebo (47.2% vs 27.0%; P = 0.0016).
Teva noted that the benefits were consistent across both age subgroups and between boys and girls. The safety profile was favorable, with similar rates of adverse events in the fremanezumab and placebo arms (55% vs 49%, respectively). Serious adverse events and treatment discontinuations due to adverse events were low (≤3% and ≤1%, respectively).
Expert Commentary
"Over the last 30 years, the incidence of childhood migraine has increased, but there has been little innovation in licensed 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 [fremanezumab] in adults, and the SPACE trial has confirmed that children with episodic migraine can also benefit from [fremanezumab]. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden."
Patricia Pozo-Rosich, MD, PhD, lead investigator of the trial and head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute in Barcelona, Spain, added, "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 [favorable] safety and tolerability for the prevention of episodic migraine in children and adolescents."
Migraine in Pediatric Patients
Teva estimates that the prevalence of migraine among children is 7.7%, increasing from 5% among those aged 5 to 10 years to approximately 15% among adolescents. Fremanezumab is currently indicated for migraine prophylaxis in adults experiencing at least 4 migraine days per month. It is administered as a 225 mg / 1.5 mL single-dose injection via a pre-filled syringe or pen in some countries.
Teva is continuing to investigate the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.
