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news.GlaxoSmithKline (GSK) and Theravance have received approval in Canada for Breo Ellipta for the once-daily maintenance treatment of asthma in patients aged 18 years and older with reversible obstructive airways disease.
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Breo Ellipta is a fixed-dose combination (FDC) of the inhaled corticosteroid (ICS) fluticasone furoate and the long-acting beta2-agonist (LABA) vilanterol.
In Canada two strengths 100/25mcg and 200/25mcg of the drug have been approved for the treatment of asthma.
GSK Canada country medical officer Sally Taylor said: "Breo Ellipta, a GSK asthma treatment approved in Canada now provides physicians with a once-daily treatment option delivered via the Ellipta inhaler to meet the needs of appropriate adult patients."
Breo is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio.
Theravance president and chief executive officer Michael Aguiar said: "With today’s approval of Breo Ellipta in Canada, we are pleased to expand the number of patients able to benefit from this important medicine.
"As a once-daily ICS/LABA treatment for adults with asthma, people suffering from this chronic condition now have an additional option."
Breo and Ellipta are trademarks of Glaxo Group, used under license by GlaxoSmithKline.