Ajovy (Fremanezumab) Shows Limited Benefits for Migraine and Depression in Clinical Trial

Recent findings from a large, multinational clinical trial reveal that the migraine prevention drug Ajovy (fremanezumab) offers only marginal improvements over placebo when it comes to treating patients suffering from both migraine and comorbid major depressive disorder. Conducted over 28 weeks across 61 centers in 12 countries, the study involved 353 adults aged 18 to 70, all diagnosed with episodic or chronic migraine alongside depression.

Participants were randomized to receive either monthly doses of fremanezumab or placebo injections. The primary outcomes focused on reductions in monthly migraine days and depressive symptom severity, measured via standard scales. While the study observed statistically significant reductions in migraine days and depressive symptoms in both groups, the differences between fremanezumab and placebo did not reach levels considered clinically meaningful.

Specifically, patients treated with fremanezumab experienced a reduction of about 5.1 migraine days per month compared to a 2.9-day reduction in the placebo group. Although the drug added some benefit, it was modest and not enough to suggest substantial therapeutic advantage. Regarding depression, the Hamilton Depression Rating Scale showed a decrease of 6 points in the fremanezumab group versus 4.6 points with placebo — a difference below the predefined minimum for clinical significance.

Further assessments, including headache impact and global severity ratings, indicated that both groups improved over time, but the additional benefit offered by fremanezumab was minimal. For example, improvements in headache-related disability measured by HIT-6 scores highlighted a net benefit that did not meet the threshold for meaningful change.

The study's sponsor, Teva Pharmaceuticals, which markets fremanezumab for migraine prevention, conducted the trial with transparent reporting of results. The findings suggest that while fremanezumab can reduce migraine frequency somewhat beyond placebo, its effect might not translate into significant daily life improvements for patients with depression. These results highlight the complexity of treating comorbid migraine and depression and underscore the need for more effective therapies.

This research adds important insights into the limitations of current CGRP-targeted therapies in patients with psychiatric conditions and emphasizes the importance of personalized treatment strategies for this challenging patient population.

source: https://medicalxpress.com/news/2025-05-ajovy-clinical-trial-placebo-migraine.html