Trelegy Ellipta Gets Positive CHMP Opinion Supporting Expanded COPD Indication

(RTTNews) - GlaxoSmithKline plc (GSK, GSK.L) and Innoviva Inc. (INVA) said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has issued a positive opinion supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/ vilanterol 'FF/UMEC/VI') in a broader group of patients with moderate to severe chronic obstructive pulmonary disease or COPD 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 or LAMA and long-acting ß2-agonist or LABA. It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment or IMPACT study.

Trelegy Ellipta was originally approved in the European Union in November 2017 as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA (for effects on symptom control see section 5.1).

The proposed new indication is as a maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LABA and a LAMA (for effects on symptom control and prevention of exacerbations see section 5.1).