GSK receives approval for NUCALA™ (mepolizumab) in Canada for the treatment of severe eosinophilic asthma
10 December 2015
Mississauga, ON - NUCALA™ (mepolizumab) has been approved in Canada as add-on maintenance treatment of adult patients with uncontrolled severe eosinophilic asthma.
NUCALA™ is the first approved biologic therapy that targets interleukin-5 (IL-5) for severe asthma. IL-5 plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma.
“GSK is pleased to announce the approval of NUCALA™, and to be able to provide patients with uncontrolled severe eosinophilic asthma with this treatment option” said Sally Taylor, Country Medical Officer, Canada.
NUCALA™ is administered as a 100 mg fixed dose subcutaneous injection every four weeks. Please consult the Product Monograph posted at www.gsk.ca for complete administration and safety information. Prior to being posted online, the Product Monograph is also available by calling 1-800-387-7374.
NUCALA is a trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc.
Asthma is a chronic lung disease that inflames and narrows the airways.1 The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment.
Approximately 2.4 million people in Canada currently have asthma.2 For many of these patients, existing therapies can provide adequate control of their symptoms if used appropriately. However, less than 5% of patients with asthma cannot achieve symptom control with existing therapies.3
About severe asthma and eosinophilic inflammation
Severe asthma is defined as “asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy”.4 In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) in the lungs can affect the airways, limiting breathing and increasing the frequency of asthma attacks. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Studies suggest that approximately 36-79% of patients with severe asthma have eosinophilic airway inflammation.5, 6
GSK – one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For information, please visit www.gsk.ca
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- Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014.
- Statistics Canada. 2015
- Am J Respir Crit Care Med 2000; 162:2341–51
- Chung et al. Eur Respir J 2014; 43:343-73
- de Carvalho-Pinto RM et al. Respir Med 2012; 106:47-56
- Haldar P et al. Am J Respir Crit Care Med 2008; 178:218-24
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2014.