A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 vs Placebo for the Preventive Treatment of Episodic Migraine
Phase of Trial: Phase III
Latest Information Update: 22 Mar 2018
At a glance
- Drugs Fremanezumab (Primary)
- Indications Migraine
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms HALO-EM
- Sponsors Teva Branded Pharmaceutical Products R&D
- 02 Feb 2018 According to a Teva Pharmaceutical media release, the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults, based on results from the HALO clinical trial program.
- 18 Dec 2017 According to a Teva Pharmaceuticals media release, the U.S. FDA has accepted for review the company's Biologics License Application (BLA) for fremanezumab for the preventive treatment of migraine. Teva acquired a priority review voucher to expedite the review of fremanezumab and regulatory action is anticipated by mid-2018.
- 17 Oct 2017 According to a company media release, based on the results from the HALO clinical trial program, Teva has submitted a BLA for fremanezumab to the US FDA. The HALO clinical research program comprises phase III Chronic Migraine (Profile 264706) and Episodic Migraine (Profile 265415) clinical trials.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History