New indication supported by NATRON Phase III trial where Fasenra delayed time to first flare or worsening of disease
MISSISSAUGA, ON, Aug. 10, 2026 /CNW/ -- Health Canada has granted a Notice of Compliance (NOC) for Fasenra® (benralizumab) as an add-on to standard therapy for the treatment of patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause.1
"Benralizumab's approval for people living with hypereosinophilic syndrome represents a new therapeutic option for this rare disorder," said Dr. Luke Chen, MD, FRCPC, MMEd, Division of Hematology, Dalhousie University. "The NATRON study showed a statistically significant decrease in flares and also addressed fatigue, an important symptom that can affect patients' quality of life."
HES is a group of rare disorders characterized by persistent, significantly elevated levels of eosinophils (a type of white blood cell) in the blood and evidence of eosinophil-mediated organ or tissue damage. This may lead to progressive organ damage over time and if left untreated, may be fatal. In Canada, an estimated 2,000 to 2,500 people may be living with HES.2
"For people living with hypereosinophilic syndrome, this rare and potentially serious disease can disrupt nearly every part of daily life – from breathing and mobility to work, school and family responsibilities," said Durhane Wong-Rieger, President and CEO of the Canadian Organization for Rare Disorders. "For patients whose disease remains uncontrolled despite current treatments, Health Canada's approval represents a new treatment option for their condition."
About NATRON
NATRON was a phase III, multicentre, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy and safety of benralizumab 30 mg versus placebo administered subcutaneously every four weeks in eligible people with HES. The primary efficacy endpoint was time to first HES worsening or flare defined as HES clinical manifestations or lab abnormalities that result in an increase/burst of oral corticosteroids (OCS)≥10 mg/day for at least 2 days, or an increase or addition of new cytotoxic and/or immunosuppressive therapy or hospitalization.
Participants (n=133) were randomized in a 1:1 ratio to receive benralizumab (30 mg or placebo every 4 weeks for 24 weeks Double Blind treatment period), in addition to background HES therapy.
The trial successfully met the primary endpoint, as treatment with benralizumab delayed the time to first HES worsening/flare and significantly reduced the risk of HES flare compared to placebo by 65% (19.4% vs 42.4% patients who experienced disease worsening or flares; HR 0.35; 95% CI: 0.18, 0.69; P=0.0024).3 Key secondary endpoints included the proportion of patients with HES flares during the 24-week treatment period, annualized rate of HES flares, time to first hematological relapse (defined as eosinophil count ≥1000 cells/mcL), and change from baseline to Week 24 in PROMIS Fatigue scores. The safety and tolerability profile for benralizumab in the NATRON trial was consistent with the known profile of the medicine.
About Fasenra
Fasenra is also indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma as well as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and Biopharmaceuticals, including Cardiovascular, Renal & Metabolic, and Respiratory & Immunology. In Canada, the company employs roughly 2,700 people and was recently named one of Canada's Top 100 Employers for the third consecutive year. AstraZeneca is one of Canada's leading R&D contributors across all sectors. Together with Alexion Rare Disease and Fusion Pharmaceuticals, AstraZeneca is delivering more than 180 clinical studies across Canada – in such areas as breast, lung, and urothelial cancers, COPD, acute kidney failure, and hypophosphatasia (HPP). Visit www.astrazeneca.ca for more information.
The content in this document is for Canadian audiences only.
References:
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1 AstraZeneca Canada Inc., FASENRA® (benralizumab injection), Product Monograph. August 2026. |
2 Data extrapolated from T. Pongdee, et al. Incidence and Prevalence of Hypereosinophilic Syndrome (HES) in the US: A Retrospective Claims Database Study. The Journal of Allergy and Clinical Immunology. Volume 157, Issue 2, Supplement AB245, February 2026 https://www.jacionline.org/article/S0091-6749%2825%2901915-3. |
3 Ogbogu, P.U., Roufosse, F., Akuthota, P. et al. Benralizumab versus placebo for hypereosinophilic syndrome: a randomized, placebo-controlled phase 3 trial. Nat Med 32, 2017–2025 (2026). https://doi.org/10.1038/s41591-026-04315-8. |
SOURCE AstraZeneca Canada Inc.
AstraZeneca Canada, Email: [email protected]
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