GlaxoSmithKline plc and Innoviva, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion today 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 (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 (LAMA) and long-acting β2-agonist (LABA). It would also reference the effect on exacerbations based on data from the InforMing the PAthway of COPD Treatment (IMPACT) study.
Dr. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said, "Many patients with COPD continue to experience exacerbations despite taking dual bronchodilator therapies. The landmark IMPACT study provided compelling evidence on the role Trelegy Ellipta can play in reducing these debilitating events. If approved, the indication will recognise this and be expanded to enable more appropriate patients to access the first once-daily single inhaler triple therapy."
The CHMP's recommendation is based on a type II variation supported by data from the IMPACT study which showed Trelegy Ellipta was superior to the inhaled corticosteroid (ICS)/LABA Relvar/Breo Ellipta (FF/VI) and LAMA/LABA Anoro Ellipta (UMEC/VI) in patients with moderate to severe COPD on multiple clinically important endpoints, including reducing exacerbations and improving lung function and health related quality of life.
Dr Ted Witek, Senior Vice President and Chief Scientific Officer at Innoviva, added: "We welcome the CHMP's recognition of the evidence supporting use of once-daily single inhaler triple therapy in a broader group of appropriate patients with COPD and look forward to a decision from the European Commission in due course."
Trelegy Ellipta was originally approved in the European Union (EU) 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). 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).
A CHMP positive opinion is one of the final steps before a final decision on the regulatory update is granted by the European Commission.