NEJM Publishes Phase 3 Data Showing Ajovy Reduces Pediatric Migraine Days
The report underpins U.S. approval for use in 6–17 year‑olds who weigh at least 45 kg.
Overview
- SPACE, a 12‑week randomized, double‑blind, placebo‑controlled trial, enrolled 237 children and adolescents aged 6–17 with episodic migraine.
- Ajovy cut monthly migraine days by 2.5 versus 1.4 with placebo, a difference of 1.1 days with statistical significance (P=0.02).
- Monthly headache days of at least moderate severity fell by 2.6 with Ajovy versus 1.5 with placebo, also a 1.1‑day advantage (P=0.02).
- Forty‑seven percent of participants on Ajovy achieved at least a 50% reduction in monthly migraine days compared with 27% on placebo (P=0.002).
- No new safety signals were identified, dosing was monthly and weight‑based (120 mg for <45 kg; 225 mg for ≥45 kg), and Teva presents Ajovy as the first CGRP antagonist with both adult and pediatric indications.