LONDON (Alliance News) - GlaxoSmithKline PLC said Theravance Inc said Friday the US Food and Drug Administration has approved Breo Ellipta for the treatment of asthma in patients over the age of eighteen.
The efficacy and safety of the treatment was studied in a clinical trial with over 12,000 subjects in 23 studies of patients aged twelve and over, Glaxo said.
Breo is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol, administered using the Ellipta dry powder inhaler.
"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," said Senior Vice President and Head of Glaxo's Global Respiratory Franchise Darrell Baker in a statement.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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