Ajovy Treatment Effective for Children, Adolescents with Episodic Migraine According to New Results from SPACE Trial

Treatment with Ajovy (fremanezumab-vfrm; Teva Pharmaceuticals, Parsippany, NJ) significantly reduced monthly migraine days and monthly headache days in children and adolescents with episodic migraine compared with those taking placebo, according to phase 3 data from the SPACE clinical trial (NCT04458857) published in The New England Journal of Medicine. The findings follow the Food and Drug Administration’s (FDA’s) August 2025 decision to approve Ajovy for the preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years who weigh at least 45 kg, which extended its previously established indication in adults.

SPACE was a randomized, double-blind, placebo-controlled, 3-month phase 3 study that enrolled 237 children and adolescents aged 6 to 17 years with episodic migraine, defined as a history of migraine for at least 6 months and no more than 14 headache days per month. Participants were randomized to receive monthly subcutaneous Ajovy treatment (120 mg for those weighing <45 kg [n=36] and 225 mg for those weighing ≥45 [n=87]) or matched placebo (n=111). The primary end point was change from baseline in average monthly migraine days, with key secondary end points including change in monthly headache days of at least moderate severity and the proportion of participants achieving a 50% or greater reduction in monthly migraine days.

Key findings from the SPACE trial include the following:

• Ajovy treatment reduced monthly migraine days by a mean of 2.5 days vs 1.4 days in those treated with placebo, corresponding to a between-group difference of 1.1 days (P=.02).
• Monthly headache days of at least moderate severity decreased by 2.6 days with Ajovy treatment vs 1.5 days in those treated with placebo (difference, 1.1 days; P=.02).
• A 50% or greater reduction in monthly migraine days was achieved by 47.2% of participants receiving Ajovy treatment compared with 27.0% of those receiving placebo (P=.002).
• Injection-site erythema was the most common adverse event, occurring in 9.8% of participants in the Ajovy group and 5.4% in the placebo group, with no new safety signals identified.

Source: Hershey AD, Szperka CL, Barbanti P, et al. Fremanezumab in children and adolescents with episodic migraine. 2026;394(3):243-252. doi:10.1056/NEJMoa2504546

Teva Pharmaceuticals. Ajovy (fremanezumab-vfrm) significantly reduced monthly migraine and headache days in children and adolescents with episodic migraine compared to placebo in the SPACE trial; results published in New England Journal of Medicine. Teva Investor Relations. Published January 14, 2026. Accessed January 16, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/AJOVY-fremanezumab-vfrm-Significantly-Reduced-Monthly-Migraine-and-Headache-Days-in-Children-and-Adolescents-with-Episodic-Migraine-Compared-to-Placebo-in-the-SPACE-Trial-Results-Published-in-New-England-Journal-of-Medicine/default.aspx