CHMP recommends benralizumab as add on maintenance therapy for severe eosinophilic asthma. AstraZeneca.

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation of benralizumab as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting b-agonists.

The CHMP recommendation is based on results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and Phase III oral corticosteroid (OCS)-sparing trial, ZONDA. Results for the 8-week dosing benralizumab regimen from these trials showed: Up to 51% reduction in the annual asthma exacerbations rate (AERR) versus placebo. Rapid improvement in lung function (290mL increase in forced expiratory volume in one second (FEV1) from baseline at 4 weeks) after the first dose, providing an early indication of effectiveness. 75% median reduction in daily OCS use and discontinuation of OCS use in 52% of eligible patients. An overall adverse event profile similar to placebo.

Benralizumab is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours. 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.

Benralizumab is also under regulatory review in the US, Japan and several other countries, with a US PDUFA date during the fourth quarter of 2017 and expected regulatory decisions elsewhere during the first half of 2018..