FDA

Ajovy now approved for migraine prophylaxis in children and adolescents

August 11, 2025

FDA approved Ajovy (fremanezumab-vfrm) for the preventive treatment of episodic migraine in children and adolescents aged 6 to 17 years who weigh ≥45 kg (99 pounds).

Ajovy is a calcitonin gene-related peptide (CGRP) antagonist that was originally approved for the preventive treatment of migraine in adults in 2018.

Efficacy

The efficacy of Ajovy for the preventive treatment of episodic migraine in pediatric patients was evaluated in the multicenter, randomized, 3-month, double-blind, placebo-controlled SPACE trial (NCT04458857) involving patients 6 to 17 years of age with a history of episodic migraine (<15 headache days per month). Participants were randomized (1:1) to receive monthly SC injections of either Ajovy or placebo, over a 3-month period. Patients who weighed ≥45 kg received Ajovy 225 mg and those who weighed <45 kg received Ajovy 120 mg. The use of acute headache treatments was allowed during the study. A subset of patients (21%) was allowed to use up to two additional concomitant preventive medications. The study excluded patients with clinically significant CV disease.

The primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period. Secondary endpoints included the proportion of patients reaching ≥50% reduction in monthly average number of migraine days during the 3-month treatment period; the mean change from baseline in the monthly average number of days of use of any acute headache medication during the 3-month treatment period; and the mean change from baseline in monthly average number of headache days of at least moderate severity during the 3-month treatment period.

A total of 235 patients (130 females, 105 males) were randomized. A total of 225 patients completed the 3-month, double-blind treatment period.

Compared with placebo, treatment with fremanezumab led to a significantly greater reduction in monthly migraine days (-2.5 vs -1.4; difference, -1.0; P =.021), monthly headache days of at least moderate severity (secondary endpoint; -2.6 vs -1.5; difference, -1.1; P =.017), and monthly acute headache medication days (-2.1 vs -1.0; difference, -1.1; P =.002) over the 3-month treatment period.

In addition, more patients in the fremanezumab group achieved ≥50% reduction in monthly migraine days compared with the placebo group (47.2% vs. 27.0%; difference, 20.2%; P =.002).

Safety

The most common adverse reactions (≥5% and greater than placebo) in the SPACE trial were injection site reactions. Hypersensitivity reactions were also observed. Overall, the safety profile in pediatric patients is similar to the known safety profile in adults.

Sources:

Ajovy (fremanezumab-vfrm) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761089s031lbl.pdf Revised August 2025. Accessed August 8, 2025.

FDA approves expanded indication for Ajovy® (fremanezumab-vfrm), the first anti-CGRP preventive treatment for pediatric episodic migraine. [News release]. 2025. https://www.tevapharm.com/news-and-media/latest-news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-treatment/