Fasenra first approved biologic for severe eosinophilic asthma.

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.