In November 2017, benralizumab (Fasenra™), developed by Kyowa Hakka Kirin & AstraZeneca, received its first global approval in the USA as add-on maintenance therapy for patients with severe eosinophilic asthma who are at least 12 years old. 
Subsequently in January 2018, the drug was approved in the EU in adult patients with severe eosinophilic asthma and in Japan in patients with bronchial asthma who continue to experience exacerbations. In both cases benralizumab is approved for add-on therapy in patients whose symptoms are not adequately controlled by high-dose inhaled corticosteroids plus other long-acting beta-agonist or asthma controllers. 
Benralizumab is an interleukin-5 receptor alpha-directed (IL-5Ra) cytolytic monoclonal antibody that is given via subcutaneous injection once every 8 weeks after the first 3 doses given at 4 weeks apart.  
Benralizumab works by binding to the alpha-subunit of the IL-5 receptor and attracting natural killer cells that subsequently induce cell death and rapid, almost complete depletion of eosinophils that are associated with the inflammation and hypersensitivity of the airways observed in this patient population. This mechanism of action is different to other available anti-IL-5 therapies that neutralise circulating IL-5 and therefore block eosinophil activation. 
Benralizumab was described as “a precision biologic” by Pascal Soroit, Chief Executive of AstraZeneca. 
For patients with severe asthma, it is not just the disease that has a negative impact on daily living. “Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments,” explains Tim Harrison, Professor of Asthma and Respiratory Medicine, University of Nottingham, UK. 
It is anticipated that the novel mechanism of action and the convenient 8-week maintenance dosing regimen of benralizumab will reduce the need for chronic oral corticosteroid use and the associated complications.
The approval of benralizumab in these three major markets was supported by evidence from the phase III WINDWARD programme: particularly the exacerbation trials, SIROCCO and CALIMA and the oral corticosteroid-sparing trial ZONDA.
For further information related to this first global approval of benralizumab, please view the report in Adis’ journal Drugs, where it has been reviewed in detail based on the development milestones tracked in AdisInsight.
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