Teva declares positive data from Phase III paediatric migraine prevention trial

Teva Pharmaceutical has announced positive results from the Phase III SPACE trial of AJOVY (fremanezumab) for preventing episodic migraines in children and adolescents aged 6 to 17. This multicenter, double-blind, randomized, placebo-controlled trial evaluated fremanezumab’s safety, efficacy, and tolerability over 12 weeks with 235 participants.

The trial achieved its primary endpoint, demonstrating statistically significant superior efficacy of AJOVY compared to placebo. Safety profiles were consistent with those observed in adults, with no new safety concerns.

AJOVY, already approved for migraine prophylaxis in adults with at least four migraine days per month, is available as a 225 mg/1.5 ml single-dose injection in various formats. Patients can choose between a 225 mg monthly dose or a 675 mg quarterly dose, which can be administered either by a healthcare professional or at home.

Teva continues to explore AJOVY's effects on pediatric patients with chronic migraines.