<p>Fremanezumab (fremanezumab-vfrm; AJOVY<sup>®</sup>) is a humanized monoclonal antibody developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Fremanezumab was first approved in September 2018 in the USA for the prevention of migraine in adults. In August 2025, it was approved in the USA for the preventive treatment of episodic migraine in pediatric patients aged 6–17&#xa0;years who weigh 45&#xa0;kg or more. This article summarizes the milestones in the development of fremanezumab leading to this pediatric first approval for migraine.</p>

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Fremanezumab: Pediatric First Approval

  • Hannah A. Blair

摘要

Fremanezumab (fremanezumab-vfrm; AJOVY®) is a humanized monoclonal antibody developed by Teva Pharmaceuticals to selectively target calcitonin gene-related peptide (a vasodilatory neuropeptide involved in the pathophysiology of migraine). Fremanezumab was first approved in September 2018 in the USA for the prevention of migraine in adults. In August 2025, it was approved in the USA for the preventive treatment of episodic migraine in pediatric patients aged 6–17 years who weigh 45 kg or more. This article summarizes the milestones in the development of fremanezumab leading to this pediatric first approval for migraine.