BioCentury
ARTICLE | Clinical News

GSK, Innoviva seek expanded Relvar Ellipta label

August 11, 2017 5:52 PM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Innoviva Inc. (NASDAQ:INVA) submitted to EMA an application to expand the label for Relvar Ellipta fluticasone furoate/vilenterol (GW685698/GW64244) to treat patients whose asthma is already adequately controlled on an inhaled corticosteroid (ICS) and long-acting adrenergic receptor beta 2 agonist (LABA) combination. The product is already approved in the EU to treat patients ages ≥12 whose asthma is not adequately controlled by ICS and "as-needed" short-acting adrenergic receptor beta 2 agonist and where ICS and LABA combination is appropriate.

The product is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the LABA vilanterol administered with the dry powder Ellipta inhaler. The product is approved in the U.S., where it is known as Breo Ellipta, and EU to treat chronic obstructive pulmonary disease (COPD) and asthma...

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