The U.S. Food and Drug Administration has approved an expanded indication for fremanezumab-vfrm (Ajovy), authorizing its use for the preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years who weigh at least 45 kg. This approval makes fremanezumab-vfrm the first calcitonin gene-related peptide antagonist indicated for both pediatric episodic migraine and adult migraine prevention. The therapy is administered as a 225 mg/1.5 mL monthly subcutaneous injection and may be given in-office or at home.

Pediatric migraine affects approximately one in ten children and adolescents in the U.S. and is associated with significant functional impairment, including reduced academic performance and disrupted social activity. Despite its prevalence, treatment options for migraine prevention in this population have been limited. The expanded indication for fremanezumab-vfrm addresses this gap by offering a targeted, calcitonin gene-related peptide (CGRP)-directed option with a monthly dosing schedule designed to support adherence and reduce treatment burden.

No loading dose is required to initiate treatment. The most commonly reported adverse events in clinical trials were injection site reactions. Postmarketing surveillance of CGRP antagonists, including fremanezumab-vfrm, has identified serious hypersensitivity reactions (eg, anaphylaxis, angioedema), new-onset or worsening hypertension, and cases of Raynaud’s phenomenon. Clinicians are advised to monitor these events and discontinue treatment as appropriate.

Fremanezumab-vfrm was initially approved in 2018 for adult migraine prevention. Fremanezumab-vfrm’s expanded indication adds a preventive option for pediatric patients with episodic migraine. For full prescribing information, including safety warnings and contraindications, physicians should consult the product labeling at www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf.

Source: Teva Pharmaceuticals