Glaxosmithkline Share News (GSK)

Glaxosmithkline (GSK) has said its Breo once-daily treatment for adult asthma has been approved by the US Food and Drug Administration (FDA).Breo, developed with US pharmaceutical group Theravance, is a "fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI)", GSK explained.Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.Breo has been approved for use by patients aged 18 and older. The proposed use by patients aged 12 to 17 was not approved by the FDA, which said data did "not show adequate risk-benefit".Darrell Baker, the head of GSK's global respiratory franchise, said: "Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities."