CHMP recommends benralizumab for eosinophilic asthma
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorisation of benralizumab (Fasenra) for the treatment of severe eosinophilic asthma.
Benralizumab is indicated as an add-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroid plus long-acting beta2-agonist treatment. Patients with eosinophilic asthma have elevated levels of blood eosinophils, which increase airway inflammation and induce airway hyper-responsiveness, thus increasing asthma severity, decreasing lung function and increasing the risk of exacerbations.
Benralizumab is a humanized monoclonal antibody therapy that works by binding to the alpha chain of the IL-5 receptor (CD125) on the surface of eosinophils, inducing apoptosis (programmed cell death) and reducing eosinophilic inflammation. If approved, benralizumab will be available as a 30mg solution for injection in a prefilled syringe, administered once every eight weeks by subcutaneous injection.
The decision of the CHMP was based on the results of the WINWARD programme of phase 3 clinical trials. This included the SIROCCO and CALIMA trials, which showed that benralizumab can reduce the annual rate of asthma exacerbations and improve lung function compared with placebo in patients with severe uncontrolled eosinophilic asthma, and the ZONDA trial, which showed a 75% reduction in daily oral corticosteroid dose with benralizumab and a discontinuation of oral corticosteroids in 52% of eligible patients. The most common adverse effects included headache (8%), pharyngitis (3%), worsening asthma, upper respiratory tract infection, sinusitis, influenza and bronchitis.
The positive opinion is now being reviewed by the European Commission, which will make a final decision on marketing authorisation across the EU. NICE has already begun its appraisal of benralizumab for the treatment of severe asthma, with a publication expected in September 2018.