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NUCALA (mepolizumab) approved in Canada as the first and only biologic treatment for adults with hypereosinophilic syndrome

Mississauga, ON – NUCALA (mepolizumab) is now approved in Canada as an add-on to standard therapy for the treatment of adults with hypereosinophilic syndrome (HES) for ≥6 months without an identifiable non-hematologic secondary cause.

The approval allows for NUCALA to become the first and only targeted biologic treatment available for patients with this eosinophil-driven disease and represents the third approved indication for NUCALA, which targets eosinophilic inflammation.

“HES is a rare and complex disease with a significant unmet need that may be filled with NUCALA," said Marni Freeman, Country Medical Director at GSK Canada. “GSK is committed to improving the lives of those living with disease associated with uncontrolled eosinophilic inflammation, continuously innovating for this broad patient group. This approval brings new hope to Canadians living withhypereosinophilic syndrome and new options for the healthcare providers supporting them.”

About Hypereosinophilic Syndrome (HES)  

HES is a rare and under-diagnosed disorder, making it difficult to estimate its overall prevalence in Canada. Patients with HES have a persistent and marked overproduction of eosinophils, a type of white blood cell, that may be three times greater than normal physiological levels. When eosinophils infiltrate certain tissues, they can cause inflammation and organ damage, which, over time, can impact patients’ ability to function day-to-day. Complications can range from fever and malaise to respiratory and cardiac problems which are typically indicative of organ damage. If left untreated, the symptoms of HES become progressively worse and the disease can be life-threatening.

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 tissues1. 

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, 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. In Canada, the U.S., Japan and several other markets, it is also approved as an add-on to corticosteroids for adult patients with a rare blood vessel disease associated with increased eosinophils, called Eosinophilic Granulomatosis with Polyangiitis .

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.gsk.ca.

GSK Inquiries:

+1 905-819-3363 (Mississauga)

+1 450-680-4812 (Laval)