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AZ's Fasenra approved in Europe as an add-on for severe eosinophilic asthma

January 12, 2018 By pharmafile

AstraZeneca and its biologics R&D unit MedImmune have announced that their drug Fasenra (benralizumab) has received approval from the European Commission (EC) as an adjuvant therapy in the treatment of severe eosinophilic asthma which has been inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.

The EC’s decision was based on data generated from three Phase 3 studies comprising more than 2,500 participants, demonstrating that Fasenra produced a “significant reduction in asthma exacerbations and improved lung function and asthma symptoms” compared to placebo, when administered in addition to standard treatments.

Elevated levels of the white blood cells eosinophils is common in around half of severe asthma patients and can cause inflammation and hyper-responsiveness of the airway, which in turn exacerbates asthma severity and symptoms and leads to decreased lung function. Up to 10% of asthma cases are considered severe. Fasenra works to address this by binding directly to the IL- 5α receptor found on eosinophils and triggers programmed cell death.

AstraZeneca's Chief Medical Officer and Head of Global Medicines Development, Sean Bohen, commented: "Fasenra is our first respiratory biologic medicine," while the European approval represents "another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation."

Fasenra was awarded approval as an adjuvant treatment for severe asthma in adult patients in the US by the FDA in November last year. The drug is currently under review in a number of countries including Japan, with regulatory decisions expected in the first half of this year.

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