Teva's AJOVY® Shows Promising Phase 3 Results For Migraine In Kids

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has reported promising topline results from its Phase 3 SPACE study, which assessed the effectiveness of AJOVY (fremanezumab) in preventing episodic migraines in children and adolescents aged 6-17. The study successfully met its primary objective, showing that AJOVY (fremanezumab) was significantly more effective than a placebo over a 12-week period. The safety profile was consistent with what has been observed in adult patients, with no new safety concerns. Detailed findings from the SPACE study will be unveiled at a forthcoming medical conference later this year.

Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, at Teva Pharmaceuticals, “The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease. The SPACE data supports our ambitions to bring the proven benefits of AJOVY to children and adolescent patients who have fewer treatment options available to them. I am pleased to see that AJOVY is continuing to demonstrate its efficacy and safety in different migraine populations, including pediatric patients.”

The SPACE data mark the first Phase 3 trial results demonstrating both the safety and efficacy of an anti-CGRP monoclonal antibody for treating migraines in children. These findings are particularly notable given the absence of approved preventive treatments for migraines in younger populations. Teva is actively investigating how AJOVY (fremanezumab) affects pediatric patients with chronic migraines.

Migraine affects approximately 7.7% of children, with the prevalence rising from 5% in those aged 5 to 10 years to around 15% in adolescents. This condition can severely impact children's daily lives, causing school absences, reduced academic performance, and missed social opportunities.