Fluticasone furoate/umeclidinium/vilanterol regulatory update

GlaxoSmithKline submitted an NDA to FDA for fluticasone furoate/umeclidinium/vilanterol to treat chronic obstructive pulmonary disease (COPD). GSK plans to submit an MAA to EMA by year end. The product is a combination of 62.5 µg umeclidinium bromide, a long-acting muscarinic antagonist (LAMA); 100 µg fluticasone furoate, an inhaled corticosteroid; and 25 µg 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...