US regulators are now reviewing Teva Pharmaceutical’s experimental anti-CGRP therapy fremanezumab for the preventive treatment of migraine, and have also granted the drug a fast track designation for the prevention of cluster headache.
Fremanezumab is a monoclonal antibody designed to bind to and inhibit the activity of calcitonin gene-related peptide (CGRP), which is believed to play a role in both migraine and cluster headache.
The submission includes data from the HALO clinical trial programme, which assessed both quarterly and monthly dose regimens in studies involving more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), in which fremanezumab “achieved statistically significant results across all trial endpoints”.
Data show that the percentage of CM patients with a reduction of at least 50 percent in the average number of headache days per month was 38 percent in the fremanezumab-quarterly group, 41 percent in the fremanezumab-monthly group, and 18 percent in the placebo group.
The reduction in the average number of headache days per month was around 4.3 with fremanezumab quarterly, 4.6 with monthly dosing, and 2.5 with placebo.
The Israeli drugmaker said it acquired a priority review voucher to speed up the review of fremanezumab, and that it expects a regulatory decision by the middle of next year.