Teva announces UNITE study data at World Congress of Neurology

Teva announced that data from the UNITE study presented at the World Congress of Neurology in Montreal, Canada, show that Ajovy reduced migraine attacks and depression symptoms in migraine patients with major depressive disorder. Ajovy is currently approved for the preventive treatment of migraine in adults. UNITE6 is a double-blind, randomized, placebo-controlled, Phase 4 study sponsored by Teva investigating the efficacy, safety, and impact of fremanezumab on patients with migraine and major depressive disorder. Data revealed in an oral presentation by Verena Ramirez Campos, global senior medical director at Teva, showed that patients in the study treated with fremanezumab experienced a significant reduction in Monthly Migraine Days, or MMD, compared to patients on placebo, a reduction in MMD of -5.1 vs -2.9 for fremanezumab vs placebo. Furthermore, a significantly higher number of patients receiving fremanezumab achieved greater than or equal to 50% reduction in MMD compared to placebo during the 12 week double blind period, with a sustained reduction over the longer-term. Two further data sets were presented as posters on the study’s secondary endpoints that evaluated the impact of fremanezumab on depression8 and disability. Treatment with fremanezumab resulted in significant reductions in depression symptoms as measured by two commonly used depression rating scores. The mean change at week 12 for fremanezumab and placebo using the Hamilton Rating Scale for Depression was -6.7 vs -5.4 respectively and using the Patient Health Questionnaire-9 score was -7.8 vs -6.3 respectively. Furthermore, fremanezumab demonstrated clinically meaningful improvements in disability outcomes in the study patients with a sustained reduction in their disability over the longer term. The mean change at week 12 for fremanezumab and placebo using the Headache Impact Test score was -8.8 vs -5.2 respectively, and using the Clinical Global Impression-Severity score was -1.1 vs -0.8 respectively. These results indicate that fremanezumab has the potential to reduce the symptoms and cumulative burden of migraine and associated depression.