GSK and Theravance submit US sNDA for Breo Ellipta in asthma
US pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) have submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) as a once-daily treatment for asthma in patients aged 12 years and older, with the brand name of Breo Ellipta.
The sNDA is seeking approval for two dose regimens, 100/25mcg and 200/25mcg, administered once daily using the Ellipta dry powder inhaler.
Today’s filing is based on data generated from the comprehensive clinical development program for FF/VI in asthma. The clinical development program comprised 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma, including the Phase III efficacy and safety study of FF/VI reported in December 2013.
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