University of Lisbon

AJOVY Becomes First CGRP Antagonist Approved for Pediatric Migraine Prevention Following Positive SPACE Trial Results

- AJOVY (fremanezumab) achieved FDA approval in August 2025 for preventing episodic migraine in children and adolescents aged 6-17 years weighing 45 kg or more, making it the first CGRP antagonist indicated for both pediatric and adult migraine prevention. - The pivotal SPACE trial demonstrated that AJOVY significantly reduced monthly migraine days by 2.5 days compared to 1.4 days with placebo, with 47.2% of patients achieving a ≥50% reduction in monthly migraine days versus 27.0% with placebo. - Real-world evidence from the PEARL study reinforced AJOVY's long-term effectiveness over 24 months in adults, with over 66% of episodic migraine patients and 51.6% of chronic migraine patients achieving ≥50% reduction in monthly migraine days during the first 6 months. - The safety profile remained consistent across pediatric and adult populations, with injection site reactions being the most common adverse event and high treatment adherence rates of approximately 90% maintained throughout studies.