GlaxoSmithKline and Innoviva announced the European Commission has authorized an expanded label for once-daily Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’), recognizing 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).
“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. Hal Barron, Chief Scientific Officer and President, R&D, GSK, said.
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While bronchodilation is recognized as the foundation of COPD therapy, many patients may continue to struggle with symptoms and exacerbations over time. The expanded indication for Trelegy Ellipta 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.
“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,” Dr. Paul Meunier, VP, Respiratory Medicine at Innoviva, said.
The label update is based on data from the landmark InforMing the PAthway of COPD Treatment (IMPACT) study which showed Trelegy Ellipta was superior to both the ICS/LABA Relvar/Breo 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 (for effects on symptom control and prevention of exacerbations see section 5.1). 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.