GSK and Innoviva receive positive opinion from CHMP for Trelegy Ellipta to treat COPD


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).

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).

It 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."

“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.