The triple therapy inhaler Trelegy Ellipta (fluticasone furoate, umeclidinium, vilanterol) has received a positive recommendation from the European Medicines Agency (EMA)‘s Committee for Medicinal Products for Human Use (CHMP) to expand its use to a broader population of chronic obstructive pulmonary disease (COPD) patients.
Currently, Trelegy Ellipta, co-developed by GlaxoSmithKline (GSK) and Innoviva, is approved by the EMA and the U.S. Food and Drug Administration (FDA) as a maintenance therapy to control symptoms in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) drug. The medicine also is indicated to reduce COPD flares in patients with a history of exacerbations.
Theravance Biopharma, one of the marketing partners of Trelegy, announced in a press release that Trelegy Ellipta received a positive opinion from EMA’s CHMP on extending its indication to adults with moderate-to-severe COPD who have not responded adequately to a combination of a LABA and a long-acting muscarinic antagonist (LAMA) drug.
A green light from CHMP is one of the final steps before the European Commission gives its final approval to update a medicine’s indication.
Trelegy Ellipta is the only FDA-approved medicine combining three commonly used COPD medicines in a single inhaler to be used once daily: fluticasone furoate (FF), an ICS; umeclidinium (UMEC), a LAMA; and vilanterol (VI), a LABA. These medicines act by helping bronchi muscles relax and dilate, opening the airways, and by reducing lung inflammation.
The CHMP recommendation is based on results from the large Phase 3 study, IMPACT (NCT02164513), which included 10,355 COPD patients with a history of exacerbations. The study showed that triple therapy with Trelegy Ellipta reduced the annual rate of severe-to-moderate COPD exacerbations, compared with dual therapy with Relvar/Breo Ellipta (FF/VI) and Anoro Ellipta (UMEC/VI).
Importantly, Trelegy Ellipta also improved patients’ lung function and health-related quality of life.
Hal Barron, MD, chief scientific officer and president of R&D at GSK, said in a press release: “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 recognize this and be expanded to enable more appropriate patients to access the first once-daily single inhaler triple therapy.”
In April 2018, the FDA approved an expanded indication for Trelegy Ellipta to treat a broader population of COPD patients, namely those with airflow limitation or who have experienced an acute worsening of respiratory symptoms.