GSK study shows COPD 'superiority' for Anoro Ellipta versus rival
GlaxoSmithKline and Innoviva have published data demonstrating the superiority in improving lung function for patients with chronic obstructive pulmonary disease of their Anoro Ellipta product compared to a rival once-daily long-acting combination therapy, Stiolto Respimat.
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GSK ran an eight-week open-label, cross-over study of 236 patients with COPD to compare the two once-daily, fixed-dose therapies, which both combine a long-acting muscarinic antagonist (LAMA) and a long-acting beta agonist (LABA).
Anoro, which is delivered via the Ellipta dry powder inhaler, achieved its primary endpoint of demonstrating non-inferiority of compared to Stiolto Respimat in improving lung function by the eighth week while also demonstrating superiority, the companies said.
Anoro is a combination of 62.5mcg of umeclidinium and 25mcg of vilanterol (UMEC/VI) while Stiolto Respimat is a 5mcg tiotropium and 5mcg of olodaterol (TIO/OLO).
Both treatments demonstrated a comparable tolerability and safety profile.
"Improving lung function is a clear goal in patients with COPD," said Eric Dube, GSK's senior vice president and head of global respiratory. "The challenge for healthcare professionals to date has been the lack of differentiation within the LAMA/LABA class.
"That is why we have conducted this study, as the first in-class head-to-head comparison of two fixed-dose once-daily LAMA/LABAs. These data demonstrate that UMEC/VI (Anoro) provides superior lung function improvements to the comparator TIO/OLO."
Innoviva chief executive Michael Aguiar said: "COPD is a progressive, chronic disease, affecting over 300 million people worldwide. We believe that these data clearly demonstrate the benefit of Anoro Ellipta versus Stiolto Respimat for symptomatic moderate COPD patients whose primary therapeutic need is additional bronchodilatation and we are very pleased with these results."
Anoro was jointly developed by GSK and Innoviva, which is eligible under the partnership to receive associated royalty revenues.
FTSE 250 group Vectura receives a low single-digit percentage royalty on net sales of GSK's Ellipta products, including Anoro.