Breakthrough Results: Fremanezumab Proves Effective for Young Migraine Sufferers in Landmark Trial

BearMarketSurvivor · 2026-01-21T01:11:39+00:00

Teva Pharmaceuticals has published Phase 3 trial results for AJOVY, demonstrating its effectiveness in treating pediatric migraines. This marks AJOVY as the first CGRP antagonist for children aged 6-17. The drug reduced monthly migraine days significantly compared to placebo, and showed a consistent safety profile, leading to FDA approval.

BearMarketSurvivor

2026-01-21 01:11:39

Abstract generation in progress

Teva Pharmaceuticals has achieved a significant milestone with the publication of Phase 3 clinical trial results demonstrating the effectiveness of AJOVY (fremanezumab) in treating episodic migraine in children and adolescents. The findings, now featured in the New England Journal of Medicine, represent a watershed moment in pediatric migraine management, as AJOVY becomes the first and only calcitonin gene-related peptide (CGRP) antagonist available for young patients aged 6-17 years weighing at least 45 kilograms.

Clinical Trial Performance: What the Data Reveals

The SPACE trial enrolled 237 children and adolescents with episodic migraine in a rigorous 3-month, randomized, placebo-controlled study. Young participants received monthly subcutaneous injections—either 120 mg fremanezumab (for those under 45 kg) or 225 mg (for those 45 kg or heavier)—compared against placebo.

The results underscore AJOVY’s clinical impact. Treatment-group participants experienced a reduction of 2.5 monthly migraine days versus 1.4 days in the placebo arm. More impressively, the therapy achieved a ≥50% reduction in monthly episodic migraine days in 47.2% of subjects, substantially outperforming the 27.0% response rate observed with placebo. Additionally, AJOVY reduced monthly headache days of at least moderate severity by 2.6 days compared to 1.5 days with placebo.

Safety and Regulatory Context

A crucial finding from the SPACE trial was the absence of new safety signals. The adverse event profile observed in pediatric patients remained consistent with established safety data from adult studies, reinforcing AJOVY’s favorable risk-benefit profile across age groups. This safety consistency was instrumental in supporting the FDA approval for pediatric use.

The approval marks a transformative development for young migraine sufferers, expanding treatment options beyond traditional approaches and establishing AJOVY as the leading preventive therapy option for episodic migraine in both pediatric and adult populations.

Market Response

Following the announcement, Teva’s stock reflected investor confidence, closing at $32.64, representing a modest gain during regular trading sessions.

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