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NUCALA (mepolizumab) the first and only anti-IL-5 add-on treatment approved in Canada that targets eosinophilic inflammation in adults with chronic rhinosinusitis with nasal polyps (CRSwNP)

Mississauga, Ontario – NUCALA (mepolizumab) is now approved in Canada as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.

This is the fourth approved indication for NUCALA for Canadian patients with eosinophilic driven diseases and is the first and only anti-IL-5 add-on treatment that targets eosinophilic inflammation in adults with CRSwNP.

“As the first anti-IL-5 for Canadians living with chronic rhinosinusitis with nasal polyps, this NUCALA approval is an important new treatment option, particularly for patients with severe CRSwNP who may have previously relied on oral steroids and recurrent surgery to manage their condition,” said Marni Freeman, Country Medical Director at GSK Canada. “With more than 50 years experience in developing and manufacturing respiratory medicines, we’re proud of this new indication as it represents yet another treatment option to address the unmet medical needs of patients living with eosinophilic driven diseases.”

“Patients with CRSwNP often experience a variety of burdensome symptoms which can negatively impact physical and mental health-related quality of life, including sleep quality,” said Vanessa Foran, President and CEO, Asthma Canada. “NUCALA’s approval is important news for Canadians living with chronic rhinosinusitis with nasal polyps, offering a novel treatment option for appropriate patients who have historically had limited treatment options.”

About chronic rhinosinusitis with nasal polyps (CRSwNP)

CRSwNP is one of a variety of diseases arising from inflammation in different tissues associated with elevated levels of eosinophils, a type of white blood cell. It is often characterised by the growth of soft tissue, known as nasal polyps, in the sinuses and nasal cavity. CRSwNP can cause chronic symptoms such as nasal obstruction, loss of smell, facial pain and pressure, and nasal discharge.

About NUCALA (mepolizumab)

NUCALA (mepolizumab) is 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 eosinophils from the bone marrow and lowers the number of eosinophils in the blood, lungs and tissues. 

With 41 clinical trials, mepolizumab has been studied in over 4,000 patients across a number of eosinophilic indications and has been approved under the brand name NUCALA in Canada.

NUCALA is approved in the U.S., Europe and in over 20 other markets as an add-on maintenance treatment for adult patients with severe eosinophilic asthma. It is approved in Canada, the U.S. and Europe for paediatric use from ages 6 to 17 as an add-on treatment for severe eosinophilic asthma. Additionally, NUCALA was the first biologic therapy to be approved in Canada as an add-on to corticosteroids for adult patients with a rare blood vessel disease associated with increased eosinophils, called Eosinophilic Granulomatosis with Polyangiitis (EGPA). Recently, NUCALA has also been approved as an add-on to standard therapy for the treatment of adult patients with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

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

About GSK

GSK is a science-led global healthcare company. For further information please visit www.ca.gsk.com.

GSK Inquiries:

+1 905-819-3363 (Mississauga)

+1 450-680-4812 (Laval)