European Medicines Agency accepts submission seeking approval of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the treatment of asthma in adults

The submission is supported by data from the Phase III CAPTAIN study (n=2,436), which found the inhaled triple therapy was associated with a statistically significant improvement in lung function compared with fluticasone/vilanterol (Relvar/Breo Ellipta).

SPS commentary:

Trelegy Ellipta is licensed in the UK for maintenance treatment in adults with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist. There is currently no single inhaled triple therapy available for the treatment of asthma in Europe.


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