Posted by Michael Wonder on 19 Sep 2017
Trelegy Ellipta approved as the first once-daily single inhaler triple therapy for the treatment of appropriate patients with COPD in the US
18 September 2017 - GSK and Innoviva today announced that the 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 for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.
Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.
Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the European Union, Australia and Canada.
