GlaxoSmithKline Plc (GSK) and Innoviva Inc said on Monday the U.S. Food and Drug Administration has approved their triple drug inhaler for the treatment of chronic obstructive pulmonary disease (COPD).
GSK’s once-daily triple inhaler, the first to get U.S approval, combines the drugs fluticasone furoate, umeclidinium, and vilanterol. It is designed to use three different mechanisms to help open airways of patients with severe COPD.
The inhaler, to be sold under the brand name Trelegy Ellipta, was not indicated for the relief of acute bronchospasm or treatment of asthma, the companies said in a statement.
Last week, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the three-in-one inhaled lung drug.
(Reporting by Rama Venkat Raman in Bengaluru; Editing by Leslie Adler)