Posted by Michael Wonder on 24 Sep 2018
Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe
21 September 2018 - GlaxoSmithKline and Innoviva announced that the EMA CHMP has issued a positive opinion today supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/ vilanterol) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD.
The expanded indication for the once-daily single inhaler triple therapy would enable use by patients not adequately treated by a long-acting muscarinic receptor antagonist and long-acting β2-agonist.
It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study.
