AstraZeneca secures European approval for asthma drug

Biopharmaceutical company AstraZeneca has received approval from the European Commission (EC) for its asthma medicine Fasenra.

Results from AstraZeneca's Phase III WINDWARD programme demonstrated a significantly reduced level of asthma exacerbations, improvements in lung function and reductions in oral corticosteroid use from baseline when weighted against placebos.

Fasenra, marketed as an add-on maintenance treatment for adult patients with severe eosinophilic asthma inadequately controlled by high-dose inhaled corticosteroids and long-acting beta-antagonists, was the first respiratory biologic medicine with an 8-week maintenance dosing schedule ever approved by the EC.

Sean Bohen, chief medical officer at AstraZeneca, 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."

Tim Harrison, professor of asthma and respiratory medicine at the University of Nottingham, added: "Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments."

Fasenra had previously been granted US Food and Drug Administration (FDA) approval in November 2017.

As of 1610 GMT, AstraZeneca shares had lost 0.89% to 5,118.00p.