GlaxoSmithKline and Innoviva, Inc have announced that the European Commission has authorised an expanded label for COPD treatment once-daily Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), recognising its effect on exacerbations and making it the first single inhaler triple therapy indicated for patients with moderate to severe chronic obstructive pulmonary disease (COPD) not adequately treated with dual bronchodilation or with an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA).
While bronchodilation is recognised as the foundation of COPD therapy, many patients may continue to struggle with symptoms and exacerbations over time. The expanded indication for FF/UMEC/VI reflects the evidence supporting its potential benefits in a broader group of patients than originally indicated, giving them the option of taking a once-daily single inhaler triple therapy for the first time.
The label update is based on data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed FF/UMEC/VI was superior to both the ICS/LABA Relvar Ellipta (FF/VI) and long-acting muscarinic receptor antagonist (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.
The new indication for Trelegy Ellipta 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. It 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.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “We are pleased that the European Commission has approved the expanded use of Trelegy Ellipta as this will enable even more COPD patients to benefit from this important medicine.”
Dr. Paul Meunier, VP, Respiratory Medicine at Innoviva, added: “We are delighted that once-daily single inhaler triple therapy will now be available for COPD patients requiring a step up from dual bronchodilation, giving them a new option to help manage their disease.”
Monica Fletcher, OBE, Global Medical Expert for GSK, Research Fellow Edinburgh University and former CEO of Education for Health said: “This approval means that prescribers in the UK can now step their patients up from a LAMA/LABA to this single-inhaler triple therapy directly, in line with this new global treatment strategy, without the need for them to be prescribed an ICS/LABA first. This is an important step to simplifying the treatment pathway for COPD patients to get them the treatment that is right for them.”