Teva Pharmaceutical Industries has submitted a biologics licence application (BLA) for fremanezumab to the US Food and Drug Administration (FDA) for migraine prevention.
A migraine is an unpredictable neurological condition accompanied by symptoms such as severe head pain and physical impairment.
Fremanezumab is a fully humanised, anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody used to prevent a migraine.
Teva Pharmaceutical chief scientific officer and Global Research and Development president Dr Michael Hayden said: “The BLA submission for fremanezumab marks a very important milestone for the migraine community.
“There have been few therapeutic innovations for migraine patients in more than 25 years.
“If approved, fremanezumab will be among the first to enter the market in a new class of drugs for the preventive treatment of migraine.”
The current application includes data from the Phase III HALO clinical trial programme, which involved more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), investigating both monthly and quarterly dose regimens of fremanezumab.
Teva Pharmaceutical Migraine and Headache therapeutic area head vice-president Dr Ernesto Aycardi said: “Phase III clinical studies of fremanezumab demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in addition to demonstrating improvement in the quality of life in patients living with episodic and chronic migraine.”
The 16-week, multicentre, randomised, double-blind, placebo-controlled, parallel-group Phase III HALO EM and CM trials compared the safety, tolerability and efficacy of four dose regimens of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine.