Fluticasone furoate/umeclidinium/vilanterol regulatory update

GlaxoSmithKline moved up its expected NDA submission to FDA for fluticasone furoate/umeclidinium/vilanterol to treat chronic obstructive pulmonary disease (COPD) to by year end from 1H18 following discussions with the agency. GSK remains on track to submit an MAA in the EU by year end. The product is a combination of 62.5 ug umeclidinium bromide, a long-acting muscarinic antagonist (LAMA); 100 ug fluticasone furoate, an inhaled corticosteroid; and 25 ug vilanterol, a long-acting adrenergic receptor beta 2 agonist (LABA), delivered once-daily in GSK’s Ellipta dry powder inhaler.

Fluticasone furoate/vilanterol is approved for COPD and asthma as Breo Ellipta in the U.S. and as Relvar Ellipta in Europe. Umeclidinium bromide/vilanterol is approved as Anoro Ellipta in the U.S. and EU for COPD. ...