Theravance Biopharma Highlights Positive Headline Results from IMPACT Study of Trelegy Ellipta Announced by GlaxoSmithKline and Innoviva
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) is approved in the US for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).
In an announcement dated
- 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg); 0.91 vs 1.07 per year; p<0.001
- 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg); 0.91 vs 1.21 per year; p<0.001
In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and associated treatment comparisons:
- Change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001
- Change from baseline St. George's Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was -1.8 units; p<0.001
- Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI compared with FF/VI; p<0.001, and a 16.0% reduction in risk for FF/UMEC/VI compared with UMEC/VI; p<0.001
The InforMing the PAthway of COPD Treatment (IMPACT) study was a randomized, double-blind, 3-arm parallel group, multicenter study evaluating FF/UMEC/VI (100mcg/62.5mcg/25mcg) versus FF/VI (100mcg/25mcg) and UMEC/VI (62.5mcg/25mcg), all given once daily via the Ellipta dry powder inhaler. The total duration of the study was approximately 55 weeks consisting of a 2-week run-in period, 52-week treatment period and a 1-week safety follow-up period. Patients had moderate to very severe symptomatic COPD with a history of exacerbation in the prior 12 months. In the study, 10,355 patients were treated in over 1,035 study centers globally.
The primary efficacy endpoint was the annual rate of on-treatment moderate and severe exacerbations. This was compared for FF/UMEC/VI versus FF/VI and, FF/UMEC/VI versus UMEC/VI. Other endpoints included lung function and patient reported outcomes, including health related quality of life measures.
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S.,
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