GlaxoSmithKline’s inhaled corticosteroid Arnuity Ellipta (fluticasone furoate) has been granted approval by the US Food and Drug Administration.
The once-daily inhaler can now be prescribed for maintenance treatment of asthma, as prophylactic therapy in patients aged 12 years and older, but it is not meant to be used for relief of acute bronchospasm.
The decision, which comes on the back of clinical trial data involving more than 3,600 patients, sees Arnuity Ellipta become the first asthma treatment from GSK’s new portfolio to have gain entry to the all important US market.
Around 26 million people in the US currently have asthma, and, despite medical advances, more than half of patients continue to experience poor control and significant symptoms, notes the UK drug giant, highlighting the room for new and effective therapies to help control the disease.
GSK's dry powder inhaler Ellipta is being used to deliver a variety of therapies for asthma and chronic obstructive pulmonary disease around the globe.