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Fremanezumab Safe and Effective for Prevention of Episodic Migraine in Children: Phase 3 Data Announced
The CGRP inhibitor fremanezumab reduced both monthly migraine and monthly headache days among children aged 6 to 17 years with a favorable safety profile.
In children aged 6 to 17 years, fremanezumab (Ajovy; Teva) was associated with significant reductions in monthly migraine days (MMD) and monthly headache days (MHD) compared to placebo, according to a company news release.
Findings from the phase 3 SPACE trial found a significantly greater number of children (47.2%) reached a 50% response rate to fremanezumab vs to placebo (27.0%) over 12 weeks with a safety profile and efficacy consistent with results in pivotal phase 3 and real-world evidence studies in adults, Teva said. The benefits of treatment were similar across age groups and between sexes as well.
Migraine prevalence in the pediatric population is estimated at 7.7% and increases from 5% among children aged 5 to 10 years to approximately 15% among adolescents, according to the release. Fremanezumab, a monthly injectable calcitonin gene-related peptide (CGRP) inhibitor, is currently indicated for prevention of migraine in adults with 4 or more migraine headaches a month, according to Teva.
“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,” co-lead investigator Patricia Pozo-Rosich, MD, PhD, headache unit and research group, head of section neurology department at Vall d’Hebron Hospital and Research Institute, Barcelona, Spain, emphasized in the press release.
The safety profile of fremanezumab among the 237 pediatric participants was of primary importance and SPACE investigators reported that a similar proportion of children in the treatment and placebo groups reported 1 or more adverse events (55% and 49%, respectively). The proportion of participants with a serious AE and an AE that led to discontinuation of treatment was low in both groups (3% or less and 1% or less, respectively).
Criteria for inclusion in the trial required children have a diagnosis of migraine of 6 months or longer and a history of fewer than 14 headache days per month. Investigators analyzed subgroups by age (6 -11 years and 12 -17 years) and by sex. Over the study period of 3 months, treatment with fremanezumab resulted in significant reductions in MMD vs placebo (-2.5 vs -1.4; P = .021) and in MHD vs placebo (-2.6 vs -1.5; P = .017).
“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,” Eric Hughes, MD, PhD, Teva executive vice president, global R&D and chief medical officer, said in the statement.
"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."
The phase 3 SPACE trial findings were presented during a late breaking science session at the European Headache Congress, December 4-7, in Rotterdam, the Netherlands.
