Positive results for Relvar Ellipta lung function study in patients with well-controlled asthma.
GlaxoSmithKline plc and Innoviva, Inc. announced positive headline results from a non-inferiority lung function study, which demonstrated that patients with well-controlled asthma were able to switch to the once-daily Relvar Ellipta (fluticasone furoate/vilanterol, FF/VI) 100/25, an inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination, from the twice-daily Seretide Accuhaler (fluticasone propionate /salmeterol, FP/SAL) 250/50, without compromising their lung function.
Patients randomized to FF/VI taken once-daily maintained a lung function comparable with those randomized to the twice-daily FP/SAL [difference +19mL (95% CI: -11mL, +49mL], meeting the study’s primary endpoint, based on the lower bound (-11ml) of the 95% confidence interval falling above the non-inferiority margin of -100mL.
A third treatment arm with fluticasone propionate (FP), ICS monotherapy, was included to detect a lung function difference between treatments. Results demonstrated statistically significant differences in favor of the ICS/LABA combinations to FP (p<0.001).
The incidences of on-treatment serious adverse events (SAEs) and adverse events (AEs) of special interest were consistent with the known safety profile of FF/VI, established in asthma patients from other studies.
Eric Dube, SVP and global head of Respiratory Franchise, GSK said: “At GSK we are constantly searching for ways in which we can help patients better manage their asthma. In this positive study we have demonstrated non-inferiority for once-daily Relvar versus twice-daily Seretide on lung function. This gives us confidence that for patients who struggle taking a twice-daily treatment regimen, there may be a once-daily treatment option available, providing greater physician choice to help patients.”
Mike Aguiar, CEO of Innoviva, Inc., added: “We believe the results of this study are important for patients and physicians. They provide additional evidence that patients with persistent asthma, who are currently treated with a twice-daily ICS/LABA, in this case Seretide, can experience a similar level of benefit in lung function when treated with Relvar Ellipta, which only needs to be taken once a day.”
The study design was okay with European regulatory authorities. GSK now intends to submit this data to the European Medicines Agency (EMA).
Results from the study will be shared in future publications and presentations.
(Source: Business Wire)
Filed Under: Drug Discovery