TEVA(US:TEVA) Globenewswire·2026-01-14 22:02Core Insights - Teva Pharmaceuticals announced the publication of pivotal Phase 3 data on AJOVY in the New England Journal of Medicine, demonstrating its efficacy and safety for treating episodic migraine in children and adolescents aged 6-17 years [1][2] Efficacy and Safety - The SPACE trial showed that AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo, with a statistically significant difference of 1.1 days (P = 0.02) [2] - AJOVY also reduced monthly headache days (MHD) of at least moderate severity by 2.6 days versus 1.5 days with placebo, again showing a significant difference of 1.1 days (P = 0.02) [2] - A higher percentage of participants achieved a ≥ 50% reduction in MMD with AJOVY (47.2%) compared to placebo (27.0%), with P = 0.002 indicating statistical significance [2] - The safety profile of AJOVY remained consistent with previous adult studies, with no new safety signals identified [2][5] Study Details - The SPACE trial was a 3-month, randomized, placebo-controlled study involving 237 children and adolescents aged 6-17 years with episodic migraine [2][5] - Participants received monthly subcutaneous injections of fremanezumab (120 mg for those weighing < 45 kg; 225 mg for those weighing ≥ 45 kg) or matched placebo [2] Market Context - With an estimated 1 in 10 children and adolescents in the U.S. suffering from migraines, the need for effective preventive treatments is critical [2] - Teva aims to lead innovation in the migraine treatment space, building on the established use of AJOVY in adults [2][3] Product Information - AJOVY is the first and only CGRP antagonist approved for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more [1][5] - The product is available as a 225 mg/1.5 mL single-dose injection in a pre-filled autoinjector or syringe, and can be administered by healthcare professionals or at home by patients aged 13 and older [7]