Teva Pharmaceuticals Highlights AJOVY® Efficacy in Pediatric Migraine Following Publication in New England Journal of Medicine

Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the New England Journal of Medicine (NEJM) has published pivotal Phase 3 data demonstrating the efficacy and safety of AJOVY® (fremanezumab-vfrm) in children and adolescents with episodic migraine. These findings, derived from the SPACE study, were instrumental in supporting the U.S. Food and Drug Administration’s (FDA) approval of AJOVY for preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years who weigh 45 kilograms (99 pounds) or more. This approval positions AJOVY as the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for preventive treatment of episodic migraine in pediatric patients, complementing its established use in adult migraine.

“An estimated one in ten children and adolescents in the U.S. lives with migraine, which can severely disrupt daily routines and overall quality of life,” said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D, and Chief Medical Officer at Teva. “The publication of the SPACE trial results in the New England Journal of Medicine adds to the growing body of evidence supporting AJOVY. It builds on its proven use in adults, demonstrating that we can offer meaningful preventive options to young patients. Teva remains committed to advancing innovation in migraine care and improving outcomes for children and adolescents affected by this debilitating condition.”

The SPACE trial demonstrated that AJOVY significantly reduced monthly migraine days (MMD) by an average of 2.5 days, compared with a 1.4-day reduction for participants receiving placebo (difference: 1.1 days; P = 0.02). Monthly headache days (MHD) of at least moderate severity were reduced by 2.6 days with AJOVY, compared to 1.5 days with placebo (difference: 1.1 days; P = 0.02). Moreover, nearly half of participants (47.2%) receiving AJOVY achieved a ≥50% reduction in MMD, versus 27.0% in the placebo group (P = 0.002). Importantly, no new safety concerns were identified, and the safety profile of AJOVY in pediatric patients aligned with observations from adult studies.

The 12-week, randomized, placebo-controlled SPACE study enrolled 237 children and adolescents aged 6 to 17 years with episodic migraine. Participants were assigned to receive monthly subcutaneous injections of fremanezumab, either 120 mg for patients weighing less than 45 kg or 225 mg for those weighing 45 kg or more, or a matching placebo. The trial’s design provided robust evidence for the efficacy and tolerability of AJOVY in the pediatric population.

“Preventing migraine attacks in children and adolescents is critical not only for their physical health but also for their cognitive, social, and emotional development,” said Andrew D. Hershey, M.D., Ph.D., the study’s lead author and Endowed Chair and Director of Neurology at Cincinnati Children’s Hospital Medical Center. “The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can meaningfully reduce the frequency of migraine attacks in youth. This provides physicians with essential evidence to guide treatment decisions for a population that has historically been underserved in migraine care.”

Migraine is a neurological condition characterized by severe, recurring headaches often accompanied by nausea, vomiting, and sensitivity to light and sound. These symptoms can substantially impair daily activities, particularly in children and adolescents, leading to missed school days, reduced academic performance, and limited participation in social and recreational activities.

About AJOVY

AJOVY is approved for preventive treatment of migraine in adults, as well as episodic migraine in children and adolescents aged 6-17 years who weigh 45 kg or more. The medication is available as a 225 mg/1.5 mL single-dose injection in a pre-filled autoinjector or syringe. AJOVY can be administered by a healthcare professional or at home by patients aged 13 years or older, or by a caregiver. No initial titration or starting dose adjustment is required. Complete prescribing information is available at AJOVY Prescribing Information.

Important Safety Information

AJOVY is contraindicated in patients with known hypersensitivity to fremanezumab-vfrm or any of its excipients, as severe reactions such as anaphylaxis or angioedema have been reported. Hypersensitivity reactions including rash, pruritus, urticaria, and other drug hypersensitivity events were noted in clinical trials, with some cases requiring discontinuation or corticosteroid treatment. Postmarketing reports have identified hypertension and Raynaud’s phenomenon following CGRP antagonist therapy, and patients should be monitored accordingly. The most common adverse reactions in clinical trials were injection site reactions (≥5% of participants).

About the SPACE Study

SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of subcutaneous fremanezumab for the preventive treatment of episodic migraine in 237 pediatric patients aged 6-17 years over a 12-week period. The trial’s results support the use of AJOVY as an effective preventive therapy for children and adolescents living with episodic migraine.

With the publication of the SPACE trial data, Teva continues to advance innovative migraine treatments that address the unmet needs of both pediatric and adult populations, providing meaningful relief and helping patients maintain their daily lives.

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