{"id":29538,"date":"2025-08-28T22:30:10","date_gmt":"2025-08-28T22:30:10","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/29538\/"},"modified":"2025-08-28T22:30:10","modified_gmt":"2025-08-28T22:30:10","slug":"reaction-and-significance-of-fremanezumabs-expanded-indication-in-pediatric-migraine-patricia-pozo-rosich-md-phd","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/29538\/","title":{"rendered":"Reaction and Significance of Fremanezumab\u2019s Expanded Indication in Pediatric Migraine: Patricia Pozo-Rosich, MD, PhD"},"content":{"rendered":"

WATCH TIME: 3 minutes<\/strong><\/p>\n

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“For many years, we had no proven treatments for children and teenagers with migraine. Now, with fremanezumab, we finally have a safe and effective option that can truly make a difference.”<\/strong><\/p>\n<\/blockquote>\n

Fremanezumab (Ajovy; Teva), a fully humanized calcitonin gene-related peptide (CGRP)-targeting monoclonal antibody, was first approved in 2018 as a preventive treatment of migraine in adults, becoming the second marketed CGRP therapy behind erenumab (Aimovig; Amgen). The drug, which comes with a monthly and quarterly dosing option, is administered as a 225 mg\/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe.<\/p>\n

Earlier this month, the FDA greenlit an expanded indication for fremanezumab<\/a> to include the preventive treatment of pediatric patients with episodic migraine aged 6-17, making it the first CGRP-targeting medication approved for both pediatric and adult migraine prevention. The expanded indication was based on data from SPACE (NCT03539393), a phase 3, double-blind, placebo-controlled trial of 237 pediatric patients with a history of less than 14 headache days per month. All told, the study was considered a success, with those on fremanezumab showing statistically significantly better change in monthly migraine days and monthly headache days vs those on placebo.<\/p>\n

In the weeks following the FDA\u2019s decision, NeurologyLive\u00ae sat down with Patricia Pozo-Rosich, MD, PhD, study investigator of SPACE, who gave thoughts on the significance of having a proven therapeutic option for children and adolescents with migraine. Pozo-Rosich, who serves as head of the neurology department at the Vall d\u2019Hebron University Hospital, touched on how previous studies, such as the CHAMP trial, fueled the long-standing perception that placebo effects were too strong to overcome in pediatric populations, leaving clinicians with limited strategies beyond lifestyle interventions or off-label attempts. Furthermore, she emphasized the burden migraine places on teenagers in particular, and stressed the importance of having a safe and effective treatment to help address some of the current unmet needs.<\/p>\n

REFERENCES
1. FDA Approves Expanded Indication for AJOVY\u00ae (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine. News release. Teva Pharmaceuticals. August 6, 2025. Accessed August 25, 2025. https:\/\/www.tevapharm.com\/news-and-media\/latest-news\/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment\/
2. Teva Presents Positive Efficacy and Safety Data of AJOVY\u00ae (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial. News release. Teva Pharmaceuticals. December 4, 2024. August 25, 2025. https:\/\/ir.tevapharm.com\/news-and-events\/press-releases\/press-release-details\/2024\/Teva-Presents-Positive-Efficacy-and-Safety-Data-of-AJOVY-fremanezumab-for-the-Prevention-of-Episodic-Migraine-in-Children-and-Adolescents-from-Phase-3-SPACE-Trial\/default.aspx<\/p>\n","protected":false},"excerpt":{"rendered":"WATCH TIME: 3 minutes “For many years, we had no proven treatments for children and teenagers with migraine.…\n","protected":false},"author":2,"featured_media":29539,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[74],"tags":[18,19,17,3267,3266,82],"class_list":{"0":"post-29538","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-technology","8":"tag-eire","9":"tag-ie","10":"tag-ireland","11":"tag-neurology","12":"tag-neurologylive","13":"tag-technology"},"share_on_mastodon":{"url":"","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/29538","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=29538"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/29538\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/29539"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=29538"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=29538"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=29538"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}