The U.S. Food and Drug Administration (FDA) has approved an expanded indication for fremanezumab (Ajovy), making it the first anti-CGRP therapy approved for the prevention of episodic migraine in both adults and children aged 6–17 years weighing 45 kg or more. This marks a significant milestone in pediatric neurology, providing a much-needed treatment option for younger patients affected by this often-debilitating condition.
A Breakthrough in Pediatric Migraine Care
Until now, children and adolescents with episodic migraine have had limited FDA-approved preventive treatment options. With this new indication, Teva’s fremanezumab offers a validated and effective therapy for reducing migraine frequency in the pediatric population.
“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents,” said Chris Fox, Executive VP at Teva. “This FDA approval addresses a long-standing gap in care and offers families added support as they navigate the challenges of this condition.”
SPACE Study Results
The approval was based on the pivotal Phase 3 SPACE trial (NCT03539393), a randomized, double-blind, placebo-controlled study that enrolled 237 children and adolescents aged 6–17 years with episodic migraine (defined as fewer than 14 headache days per month). Key outcomes included:
- Monthly Migraine Days: Reduced by 2.5 days with fremanezumab vs. 1.4 days with placebo (P = 0.0210)
- Monthly Headache Days: Reduced by 2.6 days vs. 1.5 days with placebo (P = 0.0172)
- ≥50% Responder Rate: 47.2% on fremanezumab vs. 27.0% on placebo (P = 0.0016)
These benefits were consistent across age groups (6–11 and 12–17 years) and between genders.
Safety and Administration
Fremanezumab was well tolerated, with a safety profile similar to placebo. Adverse events were reported in 55% of the treatment group vs. 49% of the placebo group. Serious adverse events were rare (<3%), and discontinuation due to side effects occurred in fewer than 1% of patients.
The medication is administered as a 225 mg subcutaneous injection and is available in pre-filled syringes or autoinjectors. It remains contraindicated in individuals with known hypersensitivity to fremanezumab or its excipients. Safety labeling includes warnings for hypersensitivity, hypertension, and Raynaud’s phenomenon.
Expert Perspective
“Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being,” said Dr. Jennifer McVige, Pediatric Neurologist at the DENT Neurologic Institute. “Having an FDA-approved treatment like AJOVY offers an important, targeted option for preventive care.”
About Fremanezumab
Originally approved in 2018 for adult migraine prevention, fremanezumab targets the calcitonin gene-related peptide (CGRP) pathway, a central mechanism in migraine pathophysiology. It can be administered monthly (225 mg) or quarterly (675 mg) for adults, with pediatric use currently approved at the 225 mg dose.
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