Health Canada approves Fasenra® (benralizumab injection) for patients with severe eosinophilic asthma

Monday, February 26, 2018 Respiratory Disease News
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MISSISSAUGA, ON, Feb. 26, 2018 /CNW/ - AstraZeneca Canada today announced that Health Canada has approved Fasenra®

(benralizumab injection) as an add-on maintenance treatment for adult patients with severe eosinophilic asthma.1

"Treatment options for patients with severe eosinophilic asthma are limited, with many relying on oral steroids to manage

their symptoms, which can lead to considerable side effects," said Dr. Mark FitzGerald, Director of the Centre for Heart and Lung Health at the Vancouver Coastal Health Research Institute, University of British Columbia, and Principal Investigator of the CALIMA trial.

"Fasenra's approval means physicians have a new option for severe asthma patients with a distinct phenotype," said Dr. FitzGerald. "Its strong clinical profile offers patients the potential to experience fewer asthma attacks and thus avoid the use of oral corticosteroids, and in those patients requiring oral corticosteroids on a regular basis, the ability to reduce or even stop their use of oral corticosteroids."

Eosinophils are a type of white blood cell that are a normal part of the body's immune system.2 Elevated levels of eosinophils, seen in about half of severe asthma patients, impact airway inflammation and airway hyper-responsiveness, resulting in increased asthma severity and symptoms, decreased lung function, and increased risk of exacerbations.3,4

"Severe asthma can greatly impact patients' quality of life by limiting their capacity for physical activity, interfering with social interactions, impeding school/workplace productivity and often leads to unplanned hospital visits," said Vanessa Foran, President and CEO, Asthma Canada. "Fasenra's approval provides a much-needed option to help people with severe asthma manage this disease, so they can live active lives, symptom free."

The Health Canada approval is based on results from the WINDWARD clinical program, including the pivotal Phase III exacerbation trials.1

"We are excited to receive approval for Fasenra as this represents a significant milestone for Canadian patients with severe asthma whose disease is driven by eosinophilic inflammation," said Dr. Neil Maresky, Vice President, Scientific Affairs, AstraZeneca Canada Inc. "Fasenra is our first respiratory biologic indication in Canada, bringing us another step closer to our goal of transforming respiratory treatment for Canadian patients, particularly of severe disease." 

About Severe Asthma Asthma affects 315 million individuals worldwide5, including an estimated 3 million Canadians.6 Up to 10% of asthma patients have severe asthma3, including an estimated 250,000 Canadians6, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines, and can require the use of chronic oral corticosteroids (OCS).7

Severe, uncontrolled asthma is debilitating and potentially fatal with patients experiencing frequent exacerbations and significant limitations on lung function and quality of life. 8,9,10 Severe, uncontrolled asthma has a higher risk of mortality than severe asthma.10,11 

Severe, uncontrolled asthma can lead to a dependence on OCS, with systemic steroid exposure potentially leading to serious short- and long-term adverse effects, including weight gain, diabetes, osteoporosis, glaucoma, anxiety, depression,7,12 cardiovascular disease13 and immunosuppression.14 There is also a significant physical and socio-economic burden of severe, uncontrolled asthma with these patients accounting for 50% of asthma-related costs.15 A conservative estimate developed by the Conference Board of Canada suggests that without concerted action, the cost of asthma alone in Canada will rise to $4.2 billion by 2030.16

About Fasenra (benralizumab)Fasenra is a monoclonal antibody that recruits natural killer cells to induce direct, rapid and near-complete depletion of eosinophils.17,18 Eosinophils are the biological effector cells in approximately 50% of asthma patients, leading to frequent exacerbations, impaired lung function and asthma symptoms.3,4 Fasenra is available as a subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8-weeks thereafter.1

Fasenra is now approved in Canada, the US, the EU, Japan, and under regulatory review in several other countries. It represents the foundation of AstraZeneca's respiratory biologics portfolio of potential new medicines targeting underlying causes of respiratory disease. Fasenra is also being evaluated in chronic obstructive pulmonary disease (COPD).

Fasenra was developed by AstraZeneca with MedImmune, the company's global biologics research and development arm, and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd., Japan.

About AstraZeneca CanadaAstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of primary and specialty care medicines that transform lives. Our primary focus is on three important areas of healthcare: Cardiovascular and Metabolic disease; Oncology; and Respiratory, Inflammation and Autoimmunity. AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients worldwide. In Canada, we employ more than 675 employees across the country and our Canadian headquarters are located in Mississauga, Ontario. For more information, please visit the company's website at www.astrazeneca.ca.

REFERENCES: _______________________________1 AstraZeneca Canada Inc., FASENRA® (benralizumab), Product Monograph. Accessed February 20, 2018, available at: https://www.astrazeneca.ca/en/our-medicines.html. 2 Mukherjee M, Sehmi R, Nair P. Anti-IL5 therapy for asthma and beyond. World Allergy Organ J. 2014;7:32.3 Wenzel S. Severe asthma in adults. Am J Respir Crit Care Med. 2005;172:149-160.4 Zhang, JY and Wenzel, SE. Tissue and BAL based biomarkers in asthma. Immunol Allergy Clin North Am. 2007; 27: 623–632 (vi.).5 To T, Stanojevic S, Moores G, et al. Global asthma prevalence in adults: findings from cross-sectional world health survey. BioMed Central Public Health. 2012: 12(204).6 Asthma Canada. Asthma Facts & Stats. Available at: https://www.asthma.ca/wp-content/uploads/2017/06/Asthma-Facts-and-Stats.pdf. Last accessed February 2018.7 Global Initiative for Asthma (GINA). Online appendix. Global strategy for asthma management and prevention. Updated 2017. Available from: http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. Last accessed February 2018.8 Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014; 12; 24: 14009.9 Adelphi Real World Respiratory Disease Specific Programme. 2012-2014. [Asthma patient data file], Bollington, UK. Unpublished raw data, cited with permission.10 Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med. 2006: 100(7):1139-51.11 Fernandes AG, Souza-Machado C, Coelho RC et al. Risk factors for death in patients with severe asthma. J Bras Pneumol. 2014; 40(4): 364-372.12 Hyland ME, Whalley B, Jones RC, Masoli M. A qualitative study of the impact of severe asthma and its treatment showing that treatment burden is neglected in existing asthma assessment scales. Qual Life Res. 2015 Mar;24(3):631-9. doi: 10.1007/s11136-014-0801-x. Epub 2014 Sep 9.13 Iribarren C, Tolstykh IV, Miller MK, et al. Adult asthma and risk of coronary heart disease, cerebrovascular disease, and heart failure: a prospective study of 2 matched cohorts. Am J Epidemiol. 2012;176:1014-1024.14 Zazzali JL, Broder MS, Omachi TA, Chang E, Sun GH, Raimundo K. Risk of corticosteroid-related adverse events in asthma patients with high oral corticosteroid use. Allergy Asthma Proc. 2015 Jul-Aug;36(4):268-74. doi: 10.2500/aap.2015.36.3863.15 World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available from: http://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php. Last accessed February 2018.16 Hermus G., et al. Cost Risk Analysis for Chronic Lung Disease in Canada." The Conference Board of Canada. 2012.17 Pham TH, Damera G, Newbold P, Ranade K. Reductions in eosinophil biomarkers by benralizumab in patients with asthma. Respir Med. 2016; 111:21-29.18 Kolbeck R, Kozhich A, Koike M, et al. MEDI-563, a humanized anti–IL-5 receptor a mAb with enhanced antibody-dependent cell-mediated cytotoxicity function. J Allergy Clin Immunol. 2010 Jun;125(6):1344-1353.e2.

SOURCE AstraZeneca Canada Inc.



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