General Information

Anoro Ellipta is a combination of umeclidinium, an anticholinergic, and vilanterol, a long-acting beta2-adrenergic agonist (LABA).

Anoro Ellipta is specifically indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema.

Anoro Ellipta is supplied as a powder formulation for inhalation. The recommended dose is one inhalation of Anoro Ellipta once daily. Anoro Ellipta should be administered at the same time every day. The dose should not exceed one dose every 24 hours.

Clinical Results

FDA Approval
The FDA approval of Anoro Ellipta was based on the following trials:
Dose-ranging trials
Dose selection for the Anoro Ellipta confirmatory trials was based on dose ranging studies of the individual components: vilanterol and umeclidinium. Based on the findings from these studies, once-daily doses of umeclidinium/vilanterol 62.5 mcg/25 mcg and umeclidinium/vilanterol 125mcg/25 mcg were evaluated in the confirmatory COPD trials.
Confirmatory Trials
Two 6-month, active controlled trials enrolled 4,733 subjects, 40 yeasr of age and older, with a history of smoking. Trial 1 evaluated Anoro Ellipta (umeclidinium/vilanterol 62.5 mcg/25 mcg), umeclidinium 62.5 mcg, vilanterol 25 mcg, and placebo. The primary endpoint was change from baseline in trough (predose) FEV1 at Day 169 (defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous dose on Day 168) compared with placebo, umeclidinium 62.5 mcg, and vilanterol 25 mcg. This was reached; Anoro Ellipta demonstrated a larger increase in mean change from baseline in trough (predose) FEV1 relative to placebo, umeclidinium 62.5 mcg, and vilanterol 25 mcg. Trial 2 had a similar study design as Trial 1 but evaluated umeclidinium/vilanterol 125 mcg/25 mcg, umeclidinium 125 mcg, vilanterol 25 mcg, and placebo. Results for umeclidinium/vilanterol 125 mcg/25 mcg in Trial 2 were similar to those observed for Anoro Ellipta in Trial 1.

Literature References

Donohue JF, Maleki-Yazdi MR, Kilbride S, Mehta R, Kalberg C, Church A Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD Respiratory Medicine 2013 Oct;107(10):1538-46

Kelleher DL, Mehta RS, Jean-Francois BM, Preece AF, Blowers J, Crater GD, Thomas P Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial. PLoS One 2012;7(12):e50716

Feldman G, Walker RR, Brooks J, Mehta R, Crater G 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulmonary Pharmacology and Therapeutics 2012 Dec;25(6):465-71