Nucala is approved in Canada for use in adolescents and children aged 6 years and above with severe eosinophilic asthma

Mississauga (Ontario) – NUCALA (mepolizumab) has now been approved in Canada as an add-on maintenance treatment for use in adults, adolescents and children (aged 6 years and older) with severe eosinophilic asthma¹.

NUCALA is the first anti-Interleukin-5 (IL5) biologic to be approved for the condition in a pediatric population (as young as 6 years old) in Canada. IL-5 plays an important role in regulating the function of eosinophils, an inflammatory cell known to be active in asthma.

Dr. Alex Romanovschi, Country Medical Director, GSK Canada, said: “Severe asthma is a chronic disease that can make daily activities a challenge for adolescents, children and their caregivers. GSK has a long and established history in respiratory health innovation, with treatments for asthma, COPD and other respiratory diseases. We are pleased to announce the extension of NUCALA’s indication to adolescents and children aged 6 years and older, thereby bringing our specialty biologic medicines to patients and their families who have limited treatment options”.

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways². The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment.

About severe asthma and eosinophilic inflammation

Severe asthma is a chronic disease with symptoms that can be life-threatening³. Approximately 250,000 Canadians live with severe asthma⁴, which can have several underlying causes, including eosinophilic inflammation⁵. In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs. Studies suggest about 60% of severe asthma patients may have eosinophilic airway inflammation⁶. 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. The prevalence of severe uncontrolled eosinophilic asthma is ≤1% among treated children aged 6-17 years old. Although the proportion of severe asthmatics among children is less than adult asthma patients, the severity of disease is greater among children and adolescents as evidenced by increased emergency room visits and hospitalizations^7,8.

About NUCALA (mepolizumab)

NUCALA contains the active substance, mepolizumab, a monoclonal antibody that works by blocking a specific protein called interleukin‑5. By blocking the action of interleukin-5, NUCALA limits the production of more eosinophils from the bone marrow and lowers the number of eosinophils in the blood, lungs and tissues1.

In Canada NUCALA is indicated as add-on maintenance treatment for adults, adolescents, and children (aged 6 years and older) with severe eosinophilic asthma who:

• are inadequately controlled with high-dose inhaled corticosteroids (patients ≥ 18 years of age) or medium-to-high-dose inhaled corticosteroids (patients 6-17 years of age) and an additional asthma controller(s) (e.g., LABA); and
• have a blood eosinophil count of ≥ 150 cells/μL (0.15 GI/L) at initiation of treatment with NUCALA OR ≥ 300 cells/μL (0.3 GI/L) in the past 12 months.

NUCALA is also approved in the US, Europe and in over 20 other markets for adult patients with severe eosinophilic asthma, and in the US, Europe, and other jurisdictions for paediatric use from ages 6 to 17 as an add-on treatment for severe eosinophilic asthma. In Canada, the US, Japan and several other markets, it is approved as add-on maintenance treatment for patients with a rare blood vessel disease associated with increased eosinophils, called Eosinophilic Granulomatosis with Polyangiitis (EGPA).

NUCALA has been studied in over 3,000 patients in 21 clinical trials, across a number of eosinophilic conditions.

Please consult the Product Monograph for NUCALA at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

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.

Trademarks are owned by or licensed to the GSK group of companies.

[2] Global Initiative for Asthma. Pocket Guide for asthma management and prevention. Updated 2014

[3] Asthma Canada: Severe Asthma here

[4] Asthma Canada: Severe Asthma link here

[5] Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective J Asthma Allergy. 2014; 7:53-65.

[6] GlaxoSmithKline Data on File (Document Number: 2015N248497_00). 2015.

[7] Fitzpatrick AM, Baena-Cagnani CE, Bacharier LB. Severe asthma in childhood: recent advances in phenotyping and pathogenesis. Curr Opin Allergy Clin Immunol. 2012; 12:193-201.

[8] Chipps BE, Zieger RS, Borish L, Wenzel SK, Yegin A, Hayden ML, et al. Key findings and clinical implications from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin Immunol. 2012; 130:332-42.