AstraZeneca and its global biologics research and development arm MedImmune have received approval from the European Commission (EC) for their Fasenra (benralizumab) for the treatment of severe eosinophilic asthma in adult patients.
The monoclonal antibody has been indicated as an add-on maintenance treatment in adults whose asthma is inadequately controlled with high-dose inhaled corticosteroids and long-acting beta-agonists.
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Fasenra triggers natural killer cells to stimulate direct, fast and near-complete depletion of eosinophils.
AstraZeneca Global Medicines Development executive vice-president Sean Bohen said: “Fasenra is our first respiratory biologic medicine.
“Today’s decision from the EC follows the recent approval of Fasenra in the US, and is another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation.”
The EC approval is based on data from the WINDWARD programme that included six Phase III trials, SIROCCO, CALIMA, ZONDA, BISE, BORA and GREGALE.
Performed in a total of 2,510 subjects aged 12 and above, the randomised, double-blinded, parallel-group, placebo-controlled SIROCCO and CALIMA trials assessed the safety and efficacy of a 30mg dose of subcutaneous benralizumab over 56 weeks.
Results from these trials demonstrated a significant decrease in asthma exacerbations, along with improved lung function and asthma symptoms, when compared to placebo.
During the registrational trial ZONDA, patients administered with benralizumab are reported to have experienced statistically significant and clinically meaningful decrease in daily-maintenance, OCS use.
Fasenra is currently being further studied in the Phase III VOYAGER programme for severe chronic obstructive pulmonary disease (COPD).
