GlaxoSmithKline plc. and Theravance, Inc. today announced that the US Food and Drug Administration (FDA) has approved Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm.                             

Breo is a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate (FF) and the long-acting beta2-agonist (LABA) vilanterol (VI). 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.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said: “Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control. 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.”

Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc., said: "We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US. We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”

For more details, go to: http://www.gsk.com/en-gb/media/press-releases/2015/fda-approves-breo-ellipta-for-the-treatment-of-adults-with-asthma-in-the-us/