Israeli multinational pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced on Wednesday that the US Food and Drug Administration has approved AJOVY (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescents aged 6–17 years who weigh at least 45 kilograms.
This makes AJOVY the first calcitonin gene-related peptide (CGRP) antagonist indicated for both paediatric episodic migraine prevention and adult migraine prevention.
AJOVY is administered as a once-monthly injection, available for in-office or at-home use, aiming to support treatment adherence and reduce burden on families. Preventive therapy can help decrease the frequency of migraine attacks, enabling better day-to-day management for young patients.
According to Teva, one in ten children and adolescents in the US suffers from migraine, a condition that is often under-recognised and undertreated. This can lead to missed school days, academic difficulties, and social disruptions.
Teva highlighted that this expanded indication builds on AJOVY's established success in adults since its US approval in 2018 and underscores the company's commitment to broadening access to therapies across age groups.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval