Teva's AJOVY Receives FDA Approval for Pediatric Migraine Treatment

Teva Pharmaceuticals announced that the US FDA has approved AJOVY for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kg or more. AJOVY is the first and only calcitonin gene-related peptide antagonist indicated for preventive treatment of episodic migraine in pediatric patients and migraine in adults.

Teva Pharmaceutical Industries Ltd. announced a significant milestone in the treatment of migraines, as the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years who weigh 45 kg or more. This approval marks a first for Teva, as AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for preventive treatment of episodic migraine in pediatric patients and migraine in adults.

The approval of AJOVY for pediatric migraine prevention addresses a long-standing gap in care for children and adolescents who suffer from this disabling neurological condition. Migraines are a common yet invisible condition that can severely disrupt daily life, often leaving sufferers overlooked and misunderstood. This new indication offers a targeted approach to preventive treatment, helping to reduce the frequency of migraine attacks and improve the quality of life for young patients.

AJOVY, which was first approved for adult migraine prevention in 2018, is now available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or pre-filled syringe. It can be administered either by a healthcare professional or at home by a patient or caregiver, offering a convenient treatment option that supports adherence and reduces treatment burden for families.

The approval of AJOVY for pediatric use underscores Teva's ongoing efforts to advance and address neurological challenges. The company has demonstrated a commitment to broadening access to neuroscience therapies across age groups, building on its established success in adult patients. This expanded indication strengthens Teva's position in the competitive CGRP antagonist market, which includes Amgen's Aimovig and Eli Lilly's Emgality.

References:
[1] https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-tevas-ajovy-migraine-prevention-children-2025-08-05/
[2] https://www.ariva.de/aktien/teva-pharmaceutical-ltd-adr-aktie/news/fda-approves-expanded-indication-for-ajovy-11716191