Teva Pharmaceuticals has received US FDA approval for AJOVY (fremanezumab-vfrm) as a preventive treatment for episodic migraine in children and adolescents aged 6–17 who weigh at least 45 kilograms.
AJOVY is now the first and only calcitonin gene-related peptide (CGRP) antagonist approved for paediatric episodic migraine prevention and adult migraine treatment. The once-monthly injection can be administered in-office or at home, offering flexibility for families.
Chris Fox, Executive Vice President at Teva, said: “With this FDA approval, AJOVY now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”
Migraine affects 1 in 10 children and adolescents in the US, often leading to missed school days and disrupted social activities. Despite its prevalence, paediatric migraine remains underrecognised and undertreated.
Dr Jennifer McVige, Pediatric Neurologist at the DENT Neurologic Institute, said: “Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients.”
AJOVY was first approved in the US in 2018 for adult patients. This expanded indication reflects Teva’s commitment to advancing neuroscience therapies and improving access across age groups.
Migraine is a disabling neurological condition that causes pain, nausea and sensitivity to light and sound. In children and adolescents, it can significantly affect school performance and emotional well-being. AJOVY’s approval offers a new pathway for managing this complex condition in a population with historically limited options.
