Relvar Ellipta regulatory update
GlaxoSmithKline and Innoviva (formerly Theravance Inc.) said Japan approved an expanded label for Relvar Ellipta fluticasone furoate/vilanterol to include treatment of chronic obstructive pulmonary disease (COPD) when concurrent use of an inhaled corticosteroid and an inhaled long-acting adrenergic receptor beta 2 agonist (LABA) is required. Relvar Ellipta is already approved in Japan for asthma. Fluticasone furoate/vilanterol is approved for COPD and asthma as Breo Ellipta in the U.S. and as Relvar Ellipta in Europe. The product is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the LABA vilanterol administered with the dry powder Ellipta inhaler...
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