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."

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.