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FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine
Globenewswire· 2025-08-06 11:00
Core Viewpoint - Teva Pharmaceuticals has received FDA approval for AJOVY, making it the first calcitonin gene-related peptide (CGRP) antagonist approved for the preventive treatment of episodic migraine in pediatric patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more, thus expanding treatment options for this demographic [1][7]. Group 1: Product Information - AJOVY is indicated for the preventive treatment of episodic migraine in children and adolescents aged 6-17 years and adults, available as a 225 mg/1.5 mL single-dose injection [6][15]. - The administration of AJOVY is designed to be convenient, with options for in-office or at-home use, and it is administered once a month [2][7]. Group 2: Market Impact and Significance - The approval of AJOVY addresses a significant gap in care for pediatric migraine patients, as 1 in 10 children and adolescents in the U.S. suffer from migraines, which are often underrecognized and undertreated [3][4]. - This expansion of AJOVY's indication builds on its success in adult patients since its U.S. approval in 2018, reinforcing Teva's commitment to enhancing access to neuroscience therapies across different age groups [4][7]. Group 3: Clinical Implications - Pediatric migraines can severely disrupt daily life, affecting school performance and emotional well-being, highlighting the importance of having effective treatment options like AJOVY [5][4]. - The introduction of AJOVY is expected to help reduce the frequency of migraine attacks in younger patients, thereby improving their quality of life and daily functioning [2][4].