GlaxoSmithKline (GSK) has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for an additional adult asthma
indication for fluticasonse furoate/ umeclidinium/ vilanterol (FF/UMEC/VI; Trelegy Ellipta).
If approved, the triple-therapy single-inhaler could be the first of its kind indicated for the treatment of both asthma and chronic obstructive pulmonary disease (COPD).
The application for asthma is supported by findings from the pivotal phase 3 CAPTAIN trial, a 2436-patient assessment which showed statistically significant benefits for improved lung function in patients treated with FF/UMEC/VI versus standard dual therapy regimen.
The double-blind, active controlled, six-arm parallel group, multi-center trial randomized patients with inadequately controlled asthma to either once-daily FF/UMEC/VI, or FF/VI. Patients administered the triple therapy were given 1 of 4 doses: 100/31.25/25; 100/62.5/25; 200/31.25/25; or 200/62.5/25 mcg. FF/VI doses were either 100/25 or 200/25 mcg.
From baseline to 24 weeks, patients treated with 100/62.5/25 mcg triple therapy reported a statistically significant lung function improvement of 110 mL change in trough forced expiratory volume over 1 second (FEV1) versus 100/25 mcg dual therapy (95% CI, 66-153; P
They also found a statistically significant improvement in trough FEV1 between 200/62.5/25 mcg triple therapy and 200/25 mcg dual therapy (92 mL; 95% CI, 49-135; P
Though 2 doses of FF/UMEC/VI (100/62.5/25 and 200/62.5/25) reached 13% reduced annualized rates of patient moderate/severe exacerbations—the study’s key secondary endpoint—the findings were not considered statistically significant.
Though the full results of the CAPTAIN trial have yet to be presented in scientific meetings or in peer-reviewed publications, its positive findings were first reported in May of this year.
The particular benefit of FF/UMEC/VI in patients with asthma—which differs from COPD in its inflammatory effect, among other factors—is in its added bronchodilation, which benefits symptoms and lung function in patients who remain symptomatic on standard inhaled corticosteroid/long-acting beta agonist (ICS/LABA) combination therapy.
As Christopher Corsico, SVP Development for GSK, noted in a statement
, its supplemental indication in asthma could be historic.
“Around 30% of asthma patients adherent to ICS/LABA combination therapy still experience symptoms,” Corsico said. “This filing is an important step towards giving asthma patients an additional treatment option.”