New FDA Approval for Pediatric Migraine Prevention

The Food and Drug Administration (FDA) has approved an expanded indication for Ajovy (fremanezumab; Teva Pharmaceuticals, Parsippany, NJ), making it the first anti-calcitonin gene-related peptide (CGRP)–targeting therapy approved for the preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years who weigh ≥45 kg. The expansion adds a new treatment option for children, a population historically underserved in migraine care.

The approval was based on results from the phase 3 SPACE clinical trial (NCT03539393), a double-blind, placebo-controlled study that included 237 individuals aged 6 to 17 years with fewer than 14 headache days per month. Participants were stratified by age group (6 to 11 years and 12 to 17 years) and randomized to receive treatment with either Ajovy or placebo for 12 weeks. The primary and secondary efficacy outcomes included changes in monthly migraine days (MMD), monthly headache days (MHD), and responder rates.

Key findings from the SPACE trial include the following:

• In terms of MMD, people treated with Ajovy demonstrated a significant reduction of -2.5 days vs -1.4 days in those treated with placebo (P=.0210)
• In terms of MHD, people treated with Ajovy showed a significant reduction of -2.6 days vs -1.5 in those treated with placebo (P=.0172)
• 47.2% of individuals in the Ajovy group achieved a ≥50% response rate vs 27.0% of those treated with placebo (P=.0016)

The safety profile in pediatric patients was consistent with adult data, with similar rates of treatment-emergent adverse events between Ajovy and placebo. Serious adverse events and discontinuations were infrequent, and no new safety signals were observed.

“Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being,” said Jennifer Williams McVige, MD, Pediatric Neurologist at the DENT Neurologic Institute. “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.”

Read: The Belly and the Brain: Weight Management and Headache by Jennifer Williams McVige, MD, Ryan Bowe, MD, Lanie Masset, BS, and Abby Graff.