In a pivotal development for pediatric neurology, the US Food and Drug Administration (FDA) has granted expanded approval to Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm).
The drug is now authorized for the preventive treatment of episodic migraine in children and adolescents aged 6 to 17 years who weigh 45 kilograms (99 pounds) or more. The company boasted that the move marks Ajovy as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for migraine prevention in both pediatric and adult populations.
“With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care,” said Chris Fox, Executive Vice President at Teva. “Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents.”
Following the news, Teva’s stock rose by 26.5% in market trading, closing at $16.01, up 19% compared to the market close on the previous day (5 August).
SPACE Trial Data
The FDA’s decision is based on robust results from the Phase III SPACE clinical trial (NCT04458857), which evaluated the efficacy and safety of Ajovy in 237 pediatric patients aged 6–17 years over 12 weeks.
Key findings from the trial include:
- A statistically significant reduction in monthly migraine days (−2.5 days vs −1.4 with placebo; p=0.0210)
- A reduction in monthly headache days (−2.6 vs −1.5; p=0.0172)
- A higher rate of patients achieving a ≥50% reduction in migraine days (47.2% vs 27.0%; p=0.0016)
Benefits were observed consistently across both age groups (6–11 and 12–17) and sexes. Importantly, the drug showed a favorable safety profile, with adverse event rates comparable to placebo (55% vs 49%) and low rates of serious adverse events (≤3%) or discontinuations (<1%).
Dr. Jennifer McVige, a pediatric neurologist at the DENT Neurologic Institute, emphasized the impact: “Pediatric migraine is a complex condition that can significantly affect a child’s life, from school performance to emotional well-being. Having an FDA-approved treatment like Ajovy offers an important option.”
Ajovy, as a CGRP antagonist, targets the calcitonin gene-related peptide pathway, which is known to play a key role in the onset and progression of migraine attacks. It is administered as a once-monthly injection and can be given either in a medical office or at home, making it more accessible and manageable for families. This flexible delivery model is aimed at supporting treatment adherence and reducing the burden on caregivers and patients alike.
Ajovy was first approved for adult use in 2018. The new indication reflects Teva’s ongoing efforts to broaden access to neurological treatments across age groups.
