FDA Accepts Teva’s Supplemental BLA for Ajovy to Prevent Pediatric Migraines
Results from the Phase III SPACE trial show that Ajovy significantly reduced monthly migraines in pediatric patients between six and 17 years of age.
Image Credit: Adobe Stock Images/New Africa
The FDA has accepted Teva’s supplemental Biologics License Application (sBLA) for Ajovy (fremanezumab-vfrm) for the prevention of episodic migraine in pediatric patients between six and 17 years of age. If approved, Ajovy would become the first calcitonin gene-related peptide antagonist indicated for migraine prevention in both adult and pediatric patient populations. The sBLA is supported by data from the Phase III SPACE trial, which demonstrated statistically significant reductions in monthly migraine and headache days compared to placebo.1
“Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited,” said Eric Hughes, MD, PhD, EVP, global R&D, chief medical officer, Teva, in a press release. “As we work to bring the benefits of Ajovy to younger patients, we build upon its proven success in adults. If approved, Ajovy could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population.”
The multicenter, randomized, double-blind, placebo-controlled, parallel-group SPACE study compared the efficacy, safety, and tolerability of subcutaneous administration of Ajovy in 237 patients to compare with placebo over a 12-week period.1
Over the first three months of treatment, results showed that patients administered Ajovy experienced significant reductions in monthly migraine days compared to placebo (-2.5 vs -1.4; p=0.0210). Additionally, the treatment demonstrated a superior reduction in monthly headache days compared to placebo (-2.6 vs -1.5; p=0.0172). Further, 47.2% of children in the Ajovy group achieved at least a 50% response rate compared with 27% in the placebo group.
Ajovy was well tolerated, with a safety profile consistent with adult populations. The most common adverse events (AEs) were injection site reactions, reported in ≥5% of patients and more frequently than placebo. Serious AEs were reported in ≤3% of Ajovy-treated patients, and discontinuation due to AEs occurred in ≤1% of cases.1,2
Migraine affects an estimated 7.7% of children, with prevalence rising from 5% in children aged 5 to 10 years to approximately 15% in adolescents. According to the Cleveland Clinic, prevalence in children under seven is approximately 2.5%. Up to seven million children and adolescents in the United States experience migraines, with the condition more common in females. Migraine without aura accounts for 60% to 85% of cases in this population, while migraine with aura affects 15% to 30%.3,4
There are two specific types of migraines that affect children and adolescents. Migraine without aura occurs in anywhere from 60% to 85% of children and adolescents who have migraines. Migraine with aura occurs in anywhere from 15% to 30% of children and adolescents with migraines.3
“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 Hughes, in a December 2024 press release. "We’ve already seen the benefits of Ajovy in adults and 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.”
Ajovy is currently approved in the United States for the preventive treatment of migraine in adults and is also available in several international markets, including Canada, Australia, Japan, and across Europe.1
References
1. Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention. Teva. April 7, 2025. Accessed April 7, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-fda-filing-acceptance-for-ajovy-fremanezumab-in-pediatric-episodic-migraine-prevention/
2. Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial. Teva. December 4, 2024. Accessed April 7, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial/default.aspx
3. Migraines in Children. Cleveland Clinic. Accessed April 7, 2025. https://my.clevelandclinic.org/health/diseases/9637-migraines-in-children-and-adolescents
4. Migraine in Children and Adolescents. Practical Neurology. May 30, 2023. Accessed April 7, 2025. https://practicalneurology.com/diseases-diagnoses/child-neurology/migraine-in-children-and-adolescents/31999/
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