A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma.
Phase of Trial: Phase III
Latest Information Update: 18 Aug 2016
At a glance
- Drugs Reslizumab (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms BREATH
- Sponsors Teva Pharmaceutical Industries
- 18 Aug 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700194454) the European Commission has granted marketing authorization for reslizumab for the treatment of asthma.
- 24 Jun 2016 According to a Teva Pharmaceuticals media release, based on the data from this and other four trials (700193046, 700194103, 700194191 & 700194454) the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization of reslizumab for the treatment of severe eosinophilic asthma. The final decision by the European Commission is expected in the second half of 2016.
- 24 Mar 2016 Primary endpoint has not been met.(Forced expiratory volume in 1 second at week 16) as per an article published in the Chest
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History