In the chronic migraine (CM) study, patients treated with fremanezumab experienced statistically significant reduction in the number of monthly headache days of at least moderate severity vs. placebo (-2.5 days) during the 12 week period after first dose, for both monthly (-4.6 days p<0.0001) and quarterly (-4.3 days p<0.0001) dosing regimens.
Similar to the Phase II trials, both patients that were on monotherapy and stable doses of prophylactic medications were included in the trial.
In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both monthly and quarterly dosing regimens, including: response rate, onset of efficacy, efficacy as monotherapy, and disability.
The results were positive, and of 13 hierarchical comparisons, p was <0.0001 in 12 of them, being 0.0004 in the remaining. The most commonly-reported adverse event in the study was injection site pain, with similar rates in the placebo and active groups.
“Migraine is a serious, debilitating neurological condition that substantially impacts all aspects of a person’s life,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “Our Phase III clinical trial program has exhibited extremely encouraging results, including with a quarterly dosing regimen, for fremanezumab in chronic migraine. We are grateful to the patients and clinical investigators who participated in this study and helped to advance our understanding of the potential of fremanezumab as a preventive treatment option for the millions of people suffering from migraine.”
“These top-line results reflect our differentiated clinical development program and add to a growing body of evidence that supports the development of CGRP targeted therapy in migraine, including patients with very severe forms of the disease, with flexible dosing regimens,” said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer & Head of Specialty Clinical Development at Teva.
“We are excited about our development progress and look forward to sharing more detailed results with the migraine community at future scientific conferences,” said Ernesto Aycardi, M.D., Vice President & Therapeutic Area Head, R&D, Migraine and Headache at Teva.
Based on these results, Teva plans to submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) for fremanezumab later this year. Teva’s Phase III HALO study in Episodic Migraine (EM) will report topline results in the coming weeks.