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GSK Reports Positive Results for Once-Daily Inhaled Corticosteroid

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GSK Reports Positive Results for Once-Daily Inhaled Corticosteroid

February 24
10:57 2017

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).

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