Teva Announces European Medicines Agency (EMA) Confirms Successful Validation of Reslizumab Marketing Authorisation Application - Seite 2

A final decision from the EMA on reslizumab is anticipated in the second half of 2016.

About Reslizumab 

Reslizumab is an investigational humanized monoclonal antibody developed to target interleukin-5 (IL-5). IL-5 is a key cytokine shown to play a crucial role in the maturation, activation and survival of eosinophils, which are a type of white blood cell that are present at elevated levels in the lungs and blood of many asthmatics. Evidence shows that eosinophils play an active role in the pathogenesis of the disease. Increased levels of eosinophils in the sputum and blood have been shown to positively correlate with disease severity and increased risk of asthma exacerbations. Reslizumab acts by binding circulating IL-5 and preventing IL-5 from interacting with its receptor.

About Asthma 

Asthma is a chronic (long term) disease usually characterized by airway inflammation and narrowing of the airways, the severity and prognosis of which can vary over time. Asthma may cause recurring periods of wheezing (a whistling sound when you breathe), chest tightness, shortness of breath and coughing that often occurs at night or early in the morning. Without appropriate treatment, asthma symptoms may become more severe and result in an asthma attack, which can lead to hospitalization and, in extreme cases, even death.

 

Notes to Editors: 

References: 

1. The Lancet Respir Med 2015, Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials, Mario Castro, James Zangrilli, Michael E Wechsler, Eric D Bateman, Guy G Brusselle, Philip Bardin, Kevin Murphy, Jorge F Maspero, Christopher O'Brien, Stephanie Korn

About Teva UK Limited 

Teva UK Limited is one of the UK's top ten pharmaceutical manufacturers, with a presence in the generics, branded respiratory, CNS and hospitals markets. It has the widest range of any UK generic pharmaceutical company and markets solid and liquid dose, injectable and respiratory medicines to healthcare professionals. The company is part of Teva Pharmaceutical Industries Ltd. For more information, visit http://www.tevauk.com.