Fremanezumab Reduces Monthly Migraine Days for Pediatric Patients

Fremanezumab-vfrm (Ajovy) reduced monthly migraine days compared with the placebo as well as monthly headache days of at least moderate severity. Data from the SPACE (NCT04458857) supported the recent approval of the drug to prevent episodic migraine in pediatric patients aged 6 to 17 years.^1,2

"With an estimated 1 in 10 children and adolescents in the US living with migraine, the need for effective preventive options is critical as this condition can disrupt daily life for patients and families," Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva, said in a news release.¹ "The SPACE trial results published in the New England Journal of Medicine add to the growing body of evidence supporting AJOVY and build on its established use in adults."

FDA Approval of Fremanezumab

In August 2025, the FDA approved fremanezumab as the first anti-calcitonin gene-related peptide for the prevention of episodic migraines in patients aged 6 to 17 years and weighing 45 kg or more. The approval was based on the SPACE trial, which investigated the drug’s efficacy against the placebo. Investigators analyzed the safety, tolerability, and immunogenicity of the drug.³

Patients received 1 of 2 doses of the study drug or the matching placebo, with the total study duration lasting for 51 months. The primary objective was to evaluate the efficacy of the drug in mean change from baseline in the monthly average number of migraine days during the 12-week study period. Secondary end points included the number of patients with treatment-emergent adverse events (AEs); the number of patients with a shift from baseline to last assessment in electrocardiogram findings; the mean change from baseline in the monthly average number of headache days of at least moderate severity during the 12-week period; the number of patients reaching at least a 50% reduction in monthly average migraine days; and the mean change from baseline in quality of life at 12 weeks.²

The Results of the Study

Of 411 patients screened, 36 received the 120 mg dose of fremanezumab, 87 received the 225 mg dose, and 112 received the placebo. The mean number of migraine days per month was 7.8 for the study drug group and 7.5 for the placebo group at baseline. Investigators found that the change from baseline in the average number of migraine days for the study drug group was 2.5 days compared with 1.4 days with the placebo, and the number of headache days per month was 2.6 days compared with 1.5 days, respectively.⁴

For a reduction of 50% or more in the number of migraine days, approximately 47.2% of patients receiving fremanezumab achieved this end point compared with 27% with the placebo. Additionally, fremanezumab reduced the average number of days per month that acute headache medication was needed by 2.1 days compared with 1 day for the placebo.⁴

As for safety, 55.3% receiving fremanezumab and 49.1% receiving the placebo experienced at least 1 AE. Most AEs were nonserious and mild to moderate in severity. Two patients in the study drug group experienced hepatitis secondary to infectious mononucleosis or migraine exacerbation, which resulted in hospitalization for both patients. Injection-site erythema was the most common adverse event, occurring in 9.8% and 5.4% of patients receiving either the study drug or the placebo, respectively.⁴

"Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability, and overall social well-being," Andrew D. Hershey, MD, PD, and Endowed Chair and director of Neurology at Cincinnati Children’s Hospital Medical Center, said in the news release.¹ "The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (Ajovy) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population."

READ MORE: Headache and Migraine Resource Center

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REFERENCES

1. 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. News release. Teva Pharmaceuticals. January 14, 2025. Accessed January 16, 2026. https://www.tevapharm.com/news-and-media/latest-news/ajovy-fremanezumab-vfrm-significantly-reduced-monthly-migraine-and-headache-days-in-children-and-adole/

2. A study to test if fremanezumab is effective in preventing episodic migraine in patients 6 to 17 years of age. ClinicalTrials.gov identification: NCT04458857. July 22, 2025. Accessed January 16, 2026. https://clinicaltrials.gov/study/NCT04458857

3. Gallagher A. FDA approves fremanezumab as first anti-CGRP drug for the prevention of pediatric episodic migraine. Drug Topics. August 6, 2025. Accessed January 16, 2026. https://www.drugtopics.com/view/fda-approves-fremanezumab-as-first-anti-cgrp-drug-for-prevention-of-pediatric-episodic-migraine

4. Hershey AD, Szperka CL, Barbanti P, et al. Fremanezumab in Children and Adolescents with Episodic Migraine. N Engl J Med. 2026;394(3):243-252. doi:10.1056/NEJMoa2504546