GSK/Theravance to file supplemental Japanese NDA for Relvar Ellipta in COPD
UK pharma major GlaxoSmithKline (LSE: GSK) and Theravance (Nasdaq: THRX) are to file a supplemental Japanese New Drug Application (sJNDA) for Relvar Ellipta (fluticasone furoate/vilanterol) to treat chronic obstructive pulmonary disease (COPD) in the first quarter of 2016.
The decision has been made following an additional global Phase III safety and efficacy study. Study 200820 provided data for the combination compared with the vilanterol component in Japanese patients with COPD, as there were insufficient efficacy data in this group within the general Phase III development program of the combination.
The study of 1,620 patients with COPD, 370 of whom were from Japan, showed that patients receiving the furoate/vilanterol combination at 100/25mcg achieved a statistically significant improvement in lung function compared with vilanterol 25mcg at 12 weeks.
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