FDA approves GSK and Theravance's asthma drug for adults

1 May 2015

The US Food and Drug Administration has approved asthma medication Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) from UK pharma major GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX).

Following submission of a supplemental New Drug Application (sNDA) to the FDA, Breo Ellipta has been approved for the once-daily treatment of asthma in patients aged 18 years and older. The drug's efficacy and safety was studied in a clinical trial programme involving over 12,000 subjects in 23 studies of patients aged 12 and over.

Darrell Baker, senior vice president and head of 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.”

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