Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) shares gained ground Thursday as the pharmaceutical concern announced today positive topline results from its Phase 3 SPACE study evaluating the efficacy of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. Safety data was consistent with that observed in adult populations, with no emergent safety signals. Full data from the SPACE study will be presented at a medical meeting later this year.
"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,” said Eric A. Hughes, Chief Medical Officer, at Teva Pharmaceuticals. "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 are the first Phase 3 trial evidence of safety and efficacy of an anti-CGRP monoclonal antibody for the treatment of migraine in a pediatric population. The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations. Teva continues to study the impact of AJOVY(fremanezumab) in pediatric patients with chronic migraine.
TEVA shares marched 39 cents, or 2.4%, to $16.76.
