GSK And Theravance Announce Submission Of SNDA To FDA For FF/VI In Asthma

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Theravance Inc. (THRX) announced the submission of a supplemental New Drug Application or sNDA to the US Food and Drug Administration or FDA for a fixed dose combination of the inhaled corticosteroid, fluticasone furoate and the long-acting beta2 agonist, vilanterol or 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.

Theravance stated that Today's filing is based upon data generated from the comprehensive clinical development programme for FF/VI in asthma. The clinical development programme 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.

Asthma is a chronic lung disease that inflames and narrows the airways, causing recurring periods of wheezing, chest tightness, shortness of breath and coughing which often occurs at night or early in the morning.