Posted by Michael Wonder on 25 Apr 2018
Once daily Trelegy Ellipta gains expanded indication in the US for the treatment of patients with COPD
24 April 2018 - GlaxoSmithKline Innoviva today announced that the US FDA has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), which means this medicine can now be used by US physicians to treat a broader population of chronic obstructive pulmonary disease patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms.
The approval is based on a supplemental new drug application supported by data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to the inhaled corticosteroid/long-acting beta2-adrenergic agonist, Relvar/Breo Ellipta, and long-acting muscarinic antagonist/long-acting beta2-adrenergic agonist, Anoro Ellipta, on multiple clinically important end-points, including reducing exacerbations and improving lung function and health related quality of life.
