AstraZeneca receives EU approval for severe asthma therapy Fasenra

AstraZeneca and MedImmune have received European regulatory approval for a promising treatment for severe eosinophilic asthma.

Fasenra has been ratified by the European Commission as an add-on maintenance treatment for adult patients with cases of severe eosinophilic asthma that are inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.

This approval was based on positive data from the phase III WINDWARD programme, during which Fasenra demonstrated significant reductions in asthma exacerbations, improvements in lung function and reductions in oral corticosteroid use versus placebo.

The drug becomes the first ever approved respiratory biologic medicine with an eight-week maintenance dosing schedule, and will be available as a fixed-dose subcutaneous injection via a prefilled syringe.

Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said this represents "another positive step towards our ambition to transform care for severe asthma patients whose disease is driven by eosinophilic inflammation".

This approval comes after the US Food and Drug Administration ratified the therapy in November 2017. It is also under regulatory review in Japan and several other countries.

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