GlaxoSmithKline, Theravance report positive Phase III data for Breo Ellipta supporting US filing in asthma

GlaxoSmithKline and Theravance revealed Friday that Breo Ellipta (fluticasone furoate/vilanterol) was associated with significant improvements in lung function in adults with asthma compared to fluticasone furoate alone, meeting the main goal of a late-stage study. "With these additional data we will consider our next steps in relation to an asthma filing in the US," commented Dave Allen, head of GlaxoSmithKline's respiratory therapy area unit.

In the study, 990 patients with moderate to severe persistent asthma were randomised to receive Breo Ellipta at one of two dose strengths or fluticasone furoate alone for 12 weeks. The companies noted that Breo Ellipta at the lower dose strength was associated with significant improvements in 0-24 hour weighted mean FEV1 compared to fluticasone furoate alone, while the higher dose strength of the combination therapy was linked to greater improvements in lung function relative to the lower dose strength.

Breo Ellipta was approved for the treatment of chronic obstructive pulmonary disease (COPD) in the US in May, and the combination therapy was authorised in Europe last month for the treatment of COPD and asthma, where it is marketed under the name Relvar Ellipta. The therapy, which consists of an inhaled corticosteroid combined with a long-acting beta-agonist, and is administered using the Ellipta dry powder inhaler, has also been cleared in Japan, Canada and Mexico.

For related analysis, read ViewPoints: Is GlaxoSmithKline's Breo Ellipta launch off to a sluggish start? and ViewPoints: Witty paints rosy picture for GlaxoSmithKline's respiratory franchise.

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