AJOVY (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine

• AJOVY demonstrated efficacy and a consistent safety profile in the SPACE trial, making it the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option for both pediatric and adult patients.^1,2
• Results from the SPACE trial found AJOVY significantly reduced monthly migraine days and monthly headache days versus placebo over a 12-week period in pediatric patients with episodic migraine.¹
• The U.S. Food and Drug Administration (FDA) approved AJOVY in August 2025 for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more, building on its initial approval for the preventive treatment of migraine in adults.²
  
  

PARSIPPANY, N.J. and TEL AVIV, Israel, Jan. 14, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the New England Journal of Medicine (NEJM) has published pivotal Phase 3 data on AJOVY, highlighting its efficacy and safety in children and adolescents with episodic migraine. The data from the SPACE study supported the FDA approval of AJOVY for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years weighing 45 kilograms (99 pounds) or more, making it the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for preventive treatment of episodic migraine in pediatric patients and migraine in adults.^1,2

"With an estimated 1 in 10 children and adolescents in the U.S. living with migraine, the need for effective preventive options is critical as this condition can disrupt daily life for patients and families," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva.³ "The SPACE trial results published in the New England Journal of Medicine add to the growing body of evidence supporting AJOVY and build on its established use in adults. Teva is proud to be leading the charge and continuing to innovate for the migraine community."

In the SPACE trial, AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo (difference: 1.1 days; P = 0.02) and reduced monthly headache days (MHD) of at least moderate severity by 2.6 days versus 1.5 days (difference: 1.1 days; P = 0.02). A significantly higher proportion of participants achieved a ≥ 50% reduction in MMD (47.2%) with AJOVY compared to placebo (27.0%) (P = 0.002). No new safety signals were identified, and the safety profile remained consistent with that observed in adult studies.¹