GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) touted data today from a non-inferiority lung function study evaluating its inhaled, once-daily corticosteroid/long-acting beta2 agonist combination therapy in patients with asthma.
The study showed that patients with well-controlled asthma could switch from the twice-daily Seretide Accuhaler to the companies’ once-daily Relvar Ellipta therapy without compromising lung function.
Patients who switched to the once-daily therapy maintained a lung function comparable to the patients treated with Seretide Accuhaler twice a day, meeting the study’s primary endpoint.
The study also evaluated a 3rd treatment arm with a monotherapy of fluticasone propionate. The results demonstrated statistically significant differences between the 3 branches, supporting the companies’ once-daily combination therapy.
“At GSK we are constantly searching for ways in which we can help patients better manage their asthma,” GlaxoSmithKline’s senior VP & global head of respiratory franchise, Eric Dube, said in prepared remarks. “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.”
The rate of on-treatment serious adverse events were consistent with the known safety profile of the combination therapy, according to the comapnies.
“We believe the results of this study are important for patients and physicians,” Innoviva CEO Mike Aguiar added. “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.”