Teva Phase III Trial of Quarterly and Monthly Dosing of Fremanezumab Meets Primary Endpoint of Reduction of Monthly Migraine Days
18 May 2018 - - Petach Tikva, Israel-based generic and specialty medicines company Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has published data from the Phase III HALO study evaluating the efficacy, safety, and tolerability of both quarterly and monthly subcutaneous dosing regimens of fremanezumab for the prevention of episodic migraine (EM), the company said.
These data were published in the online Journal of the American Medical Association.
Fremanezumab is a monoclonal antibody that selectively targets CGRP (calcitonin gene-related peptide), a neuropeptide involved in the pathophysiology of migraine.
The study evaluated the use of both quarterly and monthly dosing regimens of subcutaneous fremanezumab, compared with placebo in patients with EM (defined as 14 migraine headache days or less per month) who had previously failed multiple medication classes.
The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens
The multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 875 patients and consisted of a screening visit, 28-day pre-treatment period, 12-week treatment period, and final evaluation at week 12.
The most common adverse events in patients treated with fremanezumab were injection site pain, induration, and erythema.
Fremanezumab is an investigational therapy currently under review by the US Food and Drug Administration as a quarterly or monthly injection for the preventive treatment of migraine in adults.
Teva is a patient-centric healthcare solutions, and generic and specialty medicines producer.
It leverages its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, the company has an innovative treatment for multiple sclerosis as well as late-stage development programmes for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.