FDA Accepts BLA for Migraine Treatment, Grants Fast Track Designation for Development Program

This month, Teva Pharmaceutical Industries Ltd. announced that the U.S. FDA (Food and Drug Administration) has accepted for review the company’s BLA (Biologics License Application) for the drug fremanezumab. Teva hopes to launch fremanezumab in 2018, and it will be indicated for the preventative treatment of migraine. Fremanezumab is classified as a monoclonal antibody and it targets a component in a major pain transmission pathway in the body. This component is called the calcitonin gene-related peptide (CGRP). Fremanezumab’s priority review status and BLA was based on data from the HALO clinical trial program. This program included over 2,000 individuals with chronic migraine (CM) and episodic migraine (EM). The researchers involved in this study program investigated fremanezumab in both quarterly and monthly dose regimens. The significant results were published in the New England Journal of Medicine.

HALO study

The HALO studies were classified as a Phase 3 clinical trial program that was double-blind, randomized, placebo-controlled, and had a parallel group set-up. The program involved data from multiple centers and lasted for 16 weeks. The main goal of the studies was to evaluate the efficacy, tolerability, and safety of four different dose regimens of fremanezumab. The outcomes of those receiving fremanezumab were compared to the outcomes of their counterparts receiving a placebo. Fremanezumab was given via a subcutaneous (under the skin) injection.

Promising results

Overall, statistically significant results were found across all endpoints for those receiving fremanezumab in comparison to their placebo-receiving counterparts. The primary endpoint that was met was the mean change from baseline in the average number of headache days per month that were of moderate severity or worse in the first 3 months after taking the first dose of fremanezumab.

Cluster headache trial

Additionally, the FDA has granted fast track designation for the ENFORCE study program which is a Phase 3 clinical trial program investigating fremanezumab for the potential treatment of cluster headache. The trials are expected to finish in 2019, and are currently recruiting participants. The FDA grants fast track designation in order to aid in the quick, yet efficient, development of medications that can treat life-threatening or serious conditions. Further, there is also a Phase 2 trial currently underway, sponsored by Teva, that is investigating fremanezumab for the potential treatment of post-traumatic headache disorder.

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