Data from Pharmawand - Curated by EPG Health - Date added 11 January 2018
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.
Approval is based on Phase III WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA that demonstrated significant reductions in asthma exacerbations, improvements in lung function and reductions in oral corticosteroid use from baseline, versus placebo Fasenra is the first-ever approved respiratory biologic medicine with an 8-week maintenance dosing schedule.
Comment: Eosinophils are a type of white blood cell that are a normal part of the body's immune system. 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. Fasenra binds directly to the IL-5alpha receptor on an eosinophil and attracts natural killer cells to induce apoptosis (programmed cell death).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.