Fremanezumab Reduces Migraine Days in Children and Adolescents: NEJM

A new study published in The New England Journal of Medicine showed that Fremanezumab reduced migraine and headache days more than a placebo in children and adolescents with episodic migraine.

In children and adolescents, migraines are a common and debilitating neurological condition that frequently significantly impairs quality of life and academic performance. There are still few alternatives for preventive therapy in this group. In individuals with episodic migraine, fremanezumab, a monoclonal antibody that targets calcitonin gene-related peptide (CGRP), has demonstrated safety and effectiveness.

For younger patients, fremanezumab is a viable preventative treatment due to the pivotal role of CGRP in migraine pathogenesis. A significant unmet need in the treatment of pediatric migraines may be addressed by comprehending the function of fremanezumab in this population. Thus, this study evaluated Fremanezumab's effectiveness in treating episodic migraine in children and adolescents.

The participants aged 6 to 17 who had been diagnosed with episodic migraine (defined as migraine for ≥6 months with a history of ≤14 headache days per month) were randomly allocated to receive monthly subcutaneous injections of fremanezumab or matching placebo for 3 months. Participants were permitted to treat acute headaches with migraine-specific drugs.

The change from baseline in the average number of migraine days per month was the main outcome. A decrease of at least 50% in the number of migraine days per month and a shift in the number of days per month with headaches of at least severe severity were important secondary end goals.

234 of the 237 individuals who underwent randomization, where 123 in the fremanezumab group (36 received the 120-mg dosage and 87 received the 225-mg dose) and 111 in the placebo group were included in the entire analytic population. Fremanezumab decreased the number of migraine days per month by 2.5 compared to 1.4 with a placebo (difference, 1.1; P=0.02) and the number of days per month with a headache of at least severe severity by 2.6 compared to 1.5 with a placebo (difference, 1.1; P=0.02).

Fremanezumab reduced migraine days by 50% or more in 47.2% of individuals, whereas placebo reduced migraine days by 27.0% (P=0.002). The most frequent side effect of fremanezumab was injection-site erythema. Overall, Fremanezumab reduced the number of migraine and headache days in children and adolescents with episodic migraine more than placebo.

Source:

Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo-Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Carmeli Schwartz, Y., Ramirez Campos, V., & Ning, X. (2026). Fremanezumab in children and adolescents with episodic migraine. The New England Journal of Medicine, 394(3), 243–252. https://doi.org/10.1056/NEJMoa2504546