By VETTAPHARMA reporter: On 14th Jan 2026, Teva Pharmaceutical Industries Ltd. reported AJOVY® (fremanezumab-vfrm) demonstrated efficacy and consistent safety profile in the Phase 3 SPACE trial, making it the first and only calcitonin gene-related peptide (CGRP) antagonist treatment option approved for both pediatric and adult patients. In the 12-week, randomized study involving 237 pediatric patients, AJOVY® significantly reduced monthly migraine days by 2.5 days compared with 1.4 days for placebo, and monthly headache days by 2.6 days versus 1.5 days with placebo. 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 weighing 45 kilograms (99 pounds) or more, expanding on its prior approval for preventive treatment of adult migraine.
In addition to reductions in migraine and headache days, the trial showed that nearly half of patients treated with AJOVY® (47.2%) achieved a 50% or greater reduction in monthly migraine days, compared with 27.0% of patients receiving placebo, according to the study findings. These outcomes highlight the potential clinical benefit of preventive therapy in a pediatric population with limited approved treatment options.
Teva reported that AJOVY® was generally well tolerated in the pediatric population, with a safety profile consistent with previous studies in adults. No new safety signals were identified during the trial.
According to Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva, an estimated one in ten children and adolescents in the United States live with migraine, highlighting the critical need for effective preventive treatment options, as the condition can significantly disrupt daily life for patients and their families. He added that the SPACE trial results published in the New England Journal of Medicine contribute to the growing body of evidence supporting AJOVY, build on its established use in adults, and reflect Teva’s continued focus on innovation for the migraine community.
Source Credit
- Teva Pharmaceutical Industries Ltd. (2026, January 14). 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. Teva Investor Relations. Click here
- Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo-Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in children and adolescents with episodic migraine. New England Journal of Medicine.
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