Fremanezumab: Pediatric First Approval

<b>Declarations</b><b>Funding</b> The preparation of this review was not supported by any external funding.<b>Authorship and Conflict of interest</b> During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.<br><b>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability </b>Not applicable.Additional information about this Adis Drug Review can be found <b>here</b>.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.© Springer Nature Switzerland AG 2025