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news.The US Food and Drug Administration (FDA) has granted approval for GlaxoSmithKline (GSK) and Theravance's Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older.
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Breo is a fixed-dose combination of fluticasone furoate (FF) and vilanterol (VI) and two strengths, 100/25mcg and 200/25mcg of the combination have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
Fluticasone furoate is an inhaled corticosteroid and vilanterol is a long-acting beta2-agonist (LABA).
GSK Global Respiratory Franchise senior vice-president and head Darrell Baker 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."
Theravance president and chief executive officer Michael Aguiar 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."
The efficacy and safety of Breo Ellipta was evaluated in a clinical trial program which included more than 12,000 subjects aged 12 yearsand over in 23 studies.
The medicine is also indicated for reducing exacerbations of chronic obstructive pulmonary disease (COPD) in patients with a history of exacerbations, and is not indicated for the relief of acute bronchospasm.
Image: GlaxoSmithKline headquaters in London, UK. Photo: courtesy of Maxwell Hamilton.