FDA approves single-dose AJOVY® (fremanezumab-vfrm) injection for the preventive treatment of episodic migraine in children and adolescents aged 6-17 who weigh 45 kilograms or more, offering a long-awaited monthly treatment option with in-office or at-home administration1
AJOVY expands access across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults.
This approval marks an important step in expanding the impact of AJOVY beyond adults since its U.S. approval in 2018, and underscores Teva's ongoing efforts to advance and address neurological challenges.
Aug. 06, 2025 -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. With this approval, AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults, marking a meaningful advancement in expanding preventive treatment options for those living with migraine.
Preventative treatment can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day. AJOVY is administered once a month and available for in-office or at home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families.
"Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood," said Chris Fox, Executive Vice President, U.S. Commercial and Innovative Franchise Lead and Head of Global Marketing Business at Teva. "With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition."
1 in 10 children and adolescents in the U.S. suffer from migraine, one of the most common and disabling neurological conditions.3 Despite its widespread prevalence, pediatric migraine is often underrecognized and undertreated, contributing to missed school days, difficulties with schoolwork, and disrupted social activities.
"Pediatric migraine is a complex condition that can significantly impact a child's daily life, from school performance to emotional well-being," said Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute. "Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition."
Building on its established success in adult patients since its U.S. approval in 2018, this expanded indication strengthens Teva's commitment to broadening access to neuroscience therapies across age groups.
AJOVY continues to demonstrate efficacy in addressing the underlying biology of migraine and now provides a treatment pathway for a patient population with historically limited preventive options.
AJOVY continues to demonstrate efficacy in addressing the underlying biology of migraine and now provides a treatment pathway for a patient population with historically limited preventive options.
About Migraine
Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.5 Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.
About AJOVY
AJOVY is indicated for preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva's commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients' needs, now and in the future. At Teva, We Are All In For Better Health.
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