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FDA Approves Pediatric Migraine Treatment with AJOVY
6 Aug
Summary
- FDA approves AJOVY for episodic migraine prevention in children 6-17
- AJOVY is the first CGRP antagonist approved for pediatric migraine
- Offers monthly treatment option for in-office or at-home use

In a significant development, the U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceuticals' AJOVY (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. This approval marks an important milestone, as 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.
The approval of AJOVY for this younger patient population addresses a long-standing gap in care, as migraines are a common yet often overlooked condition that can severely disrupt the daily lives of children and adolescents. With AJOVY, these patients now have access to a targeted preventive treatment option that can help reduce the frequency of migraine attacks. The monthly injection can be administered either in-office or at home, offering families added convenience and support as they manage this neurological condition.
Teva's Executive Vice President, Chris Fox, emphasized the significance of this development, stating that AJOVY now provides "a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition." The approval builds on AJOVY's established success in adult patients since its initial U.S. approval in 2018, further strengthening Teva's commitment to expanding access to neuroscience therapies across age groups.