10 November 2017 - Recommendation based on extensive Phase III programme demonstrating significant reductions in exacerbations, improvements in lung function and reductions in oral steroid use, respectively.

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the CHMP of the EMA 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 versus placebo
  
• Rapid improvement in lung function (290 mL increase in forced expiratory volume in one second 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
  

Read AstraZeneca press release