The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for marketing authorisation of Trelegy Ellipta as a maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
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Trelegy Ellipta is the proposed brand name for fluticasone furoate / umeclidinium / vilanterol (FF / UMEC / VI), which is co-developed by GlaxoSmithKline (GSK) and Innoviva.
The therapy can be used to treat adult COPD patients who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
COPD is a common and serious form of lung disease that affects normal breathing in patients.
Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA).
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By GlobalDataIt is the first once-daily single inhaler triple treatment that has received a positive opinion from the CHMP.
Innoviva chief executive officer Mike Aguiar said: “This positive opinion will lead to a significant therapeutic convenience for those appropriate patients already on ICS / LABA treatment that require additional bronchodilation.
“Trelegy is the latest development in our collaboration with GSK and is testament to our ongoing efforts to advance respiratory medicine.”
A final decision on marketing authorisation for Trelegy Ellipta is expected to be taken by the European Commission by the end of this year.
FF / UMEC / VI is an investigational treatment that has not yet been approved for use as a single inhaler triple therapy anywhere in the world.
GSK has also received a positive opinion from CHMP for a new subcutaneous formulation of Benlysta (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity in spite of standard therapy.
Image: Micrograph showing emphysema, a type of COPD, and lung tissue with relative preservation of the alveoli. Photo: courtesy of Nephron.
