AJOVY® (fremanezumab-vfrm) Proves Effective in Reducing Migraine Days in Pediatric Patients
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, demonstrating its efficacy and safety in children and adolescents suffering from episodic migraine. This significant advancement followed the U.S. Food and Drug Administration's (FDA) approval in August 2025 for AJOVY's preventive treatment in pediatric patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more.
AJOVY's Clinical Efficacy
The SPACE trial findings revealed that AJOVY significantly reduced monthly migraine days (MMD) and headache days compared to placebo over a 12-week period. Specifically, children treated with AJOVY experienced a reduction of 2.5 MMD versus 1.4 MMD in the placebo group (difference: 1.1 days; P = 0.02). Additionally, AJOVY led to a reduction of 2.6 headache days (MHD) of at least moderate severity compared to 1.5 days for placebo, also with the same statistical significance.
A higher percentage of participants achieved a ≥ 50% reduction in MMD, with 47.2% of AJOVY recipients meeting this benchmark compared to 27.0% from the placebo group (P = 0.002). Notably, the safety profile of AJOVY remained consistent with prior studies conducted in adults.
Background on SPACE Trial and Study Design
The SPACE study was a 3-month, randomized, double-blind, placebo-controlled trial that enrolled 237 children and adolescents diagnosed with episodic migraine. Participants were randomized to receive either monthly subcutaneous injections of fremanezumab (120 mg for those <45 kg; 225 mg for those ≥45 kg) or a matched placebo.
Statements from Teva Leadership
"With an estimated 1 in 10 children and adolescents in the U.S. living with migraine, the need for effective preventive options is critical," stated Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. "The SPACE trial results strengthen the growing body of evidence supporting AJOVY and bolster its established role in adult migraine treatment.”
Andrew D. Hershey, M.D., Ph.D., the study’s lead author, emphasized the importance of preventing migraine attacks in youth, stating, “The SPACE trial demonstrates that a CGRP-targeted preventive therapy like AJOVY can significantly reduce migraine frequency, providing physicians with essential evidence for managing this underserved population.”
About Migraine and AJOVY
Migraine can cause debilitating pain, nausea, vomiting, and heightened sensitivities to light and sound. Such symptoms may significantly hinder a child's daily activities and educational performance. AJOVY is now recognized as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years.
AJOVY is available in a 225 mg/1.5 mL single-dose injection format and can be administered by a healthcare provider or at home by patients aged 13 and older or their caregivers.
Safety Profile and Important Information
As with any medication, AJOVY has contraindications. It is advised for patients with serious hypersensitivity to fremanezumab-vfrm or its excipients to avoid using AJOVY. Reactions noted in clinical trials included mild to moderate hypersensitivity reactions, injection site reactions, and, in rare cases, anaphylaxis.
About Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is evolving into a leading innovative biopharmaceutical company, focused on addressing patient needs across various therapeutic areas. Teva remains dedicated to improving health outcomes worldwide.
For comprehensive details regarding the SPACE trial and further information about AJOVY, visit the official Teva Pharmaceuticals website.