GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease.
The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol.
Patients in the FF/UMEC/VI arm showed improved lung function and fewer of the exacerbations normally seen in COPD patients. After 24 weeks, the FF/UMEC/VI cohort showed a 35% reduction versus Symbicort Turbohaler-treated patients; at 52 weeks, that number was up to 44%, Glaxo said.
“Exacerbations are a major cause of morbidity in COPD, and reducing these symptomatic and potentially life-threatening episodes is a priority for physicians. To observe such significant reductions in exacerbations with closed triple therapy versus budesonide/formoterol is encouraging and supports our belief that a convenient, once-daily triple therapy dosing option delivered via a single inhaler could provide compelling and clinically important treatment benefits in this more severe patient population,” respiratory R&D head Dave Allen said in prepared remarks.
“The results of the Fulfil study confirm that the closed triple therapy of FF/UMEC/VI is superior to dual therapy of budesonide/formoterol on the key measures of lung function, quality of life and exacerbation reduction. These results contribute to the medicine’s positive benefit/risk profile and increase understanding of the clinical value of triple therapy in those patients that physicians decide would benefit from triple therapy versus dual therapy alone,” added Innoviva CEO Mike Aguiar.
Glazo said it’s on track for regulatory submissions in the U.S. and Europe for the treatment by the end of this year.
INVA shares jumped 4.3% to $11.57 apiece yesterday and were trading at $11.47 per share early today, up 0.7%. GSK shares were holding steady at $43.85 per share this morning.
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