Topline Findings
- Ajovy becomes first FDA-approved calcitonin gene-related peptide migraine prevention for pediatric patients: New indication allows use in children aged six to 17 years with episodic migraine weighing at least 99 lbs.
- Phase III SPACE trial shows significant efficacy: Ajovy reduced monthly migraine and headache days and achieved a 50% responder rate in nearly half of pediatric patients.
- Well-tolerated with consistent safety profile: Injection site reactions were the most common adverse events; serious adverse effects and discontinuations were rare.
The FDA has approved an expanded indication for Teva’s Ajovy (fremanezumab-vfrm), making it the first and only anti-calcitonin gene-related peptide (CGRP) preventive treatment approved for pediatric patients aged six to 17 years with episodic migraine who weigh at least 99 lbs. According to the company, this approval addresses a critical unmet need in pediatric migraine care, offering a new preventive option for a population who has historically had limited access to targeted treatments.
Approval was based on data from the Phase III SPACE trial (NCT03539393), which demonstrated statistically significant reductions in monthly migraine and headache days compared to placebo.1-3
What Makes Ajovy a Breakthrough for Pediatric Migraine Prevention?
“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” said Chris Fox, EVP, US commercial and innovative franchise lead, head, global marketing business, Teva, in a press release. “With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”
Key Findings from the Phase III SPACE Trial
- The multicenter, randomized, double-blind, placebo-controlled, parallel-group SPACE trial compared the efficacy, safety, and tolerability of subcutaneous administration of Ajovy compared to placebo in 237 pediatric patients over a 12-week period.
- During the initial three months of therapy, patients receiving Ajovy saw a greater decrease in monthly migraine days compared to those on placebo (–2.5 vs –1.4; p=0.0210).
- The treatment produced a more pronounced reduction in monthly headache days versus placebo (–2.6 vs –1.5; p=0.0172).
- Moreover, 47.2% of children treated with Ajovy achieved at least a 50% reduction in migraine days, compared to 27% in the placebo group.
- Ajovy was generally well tolerated, showing a safety profile similar to that seen in adults.
- The most frequently reported adverse events (AEs) were injection site reactions, occurring in 5% or more of patients and at a higher rate than in the placebo group.
- Serious AEs were observed in 3% or fewer of those treated with Ajovy, while treatment discontinuations due to AEs occurred in 1% or fewer of cases.3
Background and Impact on Pediatric Migraine
Ajovy was first approved in September 2018 for the preventive treatment of migraine in adults.1 In January 2020, the treatment was granted its first approved expanded indication to be used as an autoinjector device.4
According to Teva, migraine affects approximately one in 10 children and adolescents in the United States, making it one of the most prevalent and disabling neurological disorders in this age group. Despite how common it is, pediatric migraine often goes undiagnosed or insufficiently treated, leading to missed classes, academic challenges, and interruptions in social life.1
Children and adolescents with migraines typically experience one of two main types. Migraine without aura is the more common form, affecting approximately 60% to 85% of young migraine sufferers. In contrast, migraine with aura affects about 15% to 30% of this population.3
"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," said Jennifer McVige, MD, MA, pediatric neurologist, DENT Neurologic Institute, in the press release. “Having an FDA-approved treatment like Ajovy offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”
References
- FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. Teva. August 6, 2025. Accessed August 6, 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/
- Fremanezumab Compassionate Use Program for Pediatric Patients. Clinicaltrials.gov. Accessed August 6, 2025. https://www.clinicaltrials.gov/study/NCT03539393?term=fremanezumab%20space&rank=1
- FDA Accepts Teva’s Supplemental BLA for Ajovy to Prevent Pediatric Migraines. PharmExec. April 8, 2025. Accessed August 6, 2025. https://www.pharmexec.com/view/fda-accepts-teva-supplemental-bla-ajovy-prevent-pediatric-migraines
- Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector. Drugs.com. Accessed August 6, 2025. https://www.drugs.com/newdrugs/teva-announces-fda-approval-ajovy-fremanezumab-vfrm-autoinjector-5152.html
