Innoviva, GlaxoSmithKline confirm FDA approval of Trelegy Ellipta
GlaxoSmithKline (GSK) and Innoviva (INVA) announced that the U.S. FDA has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or patients who are on umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.
COPD is a disease that affects the lungs, causing reduced airflow, which makes it hard to breathe. It is also progressive, which means it worsens over time. COPD can include emphysema, chronic bronchitis, or both. Roughly 15 million adults in the U.S. have been diagnosed with COPD, while millions more who have it may not even know it.
Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.
Following this approval by the FDA, Trelegy Ellipta will be available in the US shortly.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the European Union, Australia and Canada.
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