AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.1
The approval is based on the results from the WINDWARD program, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.1
“Fasenra is our first respiratory biologic medicine,” Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said. “(The) decision from the EC follows the recent approval of Fasenra in the U.S. and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.”
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
Fasenra binds directly to the IL-5α receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programed cell death).5,6,7 Fasenra will be available as a fixed-dose subcutaneous injection via a prefilled syringe administered once every 4 weeks for the first 3 doses, and then once every 8 weeks thereafter.1
In November 2017, the U.S. Food and Drug Administration (FDA) approved Fasenra for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.8 Fasenra is also under regulatory review in Japan and several other countries, with expected regulatory decisions in H1 2018.
Asthma affects 315 million individuals worldwide, and up to 10 percent of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic OCS.3,9,10
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References:
1 Fasenra (benralizumab) Summary of Product Characteristics. AstraZeneca plc, 2017.
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 FitzGerald MJ, Bleecker E, Parameswaran N, et al. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016. Volume 388, Issue 10056, 2128 – 2141.
6 Bleecker ER, Fitzgerald MJ, Chanez P, et al. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting β2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016. Volume 388, Issue 10056, 2115 – 2127.
7 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.
8 FASENRA Prescribing Information. AstraZeneca Pharmaceuticals LP.
9 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).
10 Global Initiative for Asthma (GINA). Online appendix. Global strategy for asthma management and prevention. Updated 2017. Available from: https://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention/. Last accessed November 2017.
(Source: AstraZeneca)
Filed Under: Drug Discovery
