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news.GlaxoSmithKline (GSK) and Innoviva announced that a committee of the European Medicines Agency (EMA) has adopted positive opinion for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) in treating chronic obstructive pulmonary disease (COPD) in adults.
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Proposed to have a brand name of Trelegy Ellipta, FF/UMEC/VI has been recommended for approval in Europe by the Committee for Medicinal Products for Human Use (CHMP) in treating moderate to severe forms of COPD.
The recommended approval for the once-daily single inhaler triple therapy pertains to patients who were not treated adequately by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.
GSK R&D president Patrick Vallance said: “We believe once-daily single inhaler triple therapy, if approved, would provide an important option for appropriate patients with COPD who are receiving ICS/LABA and require additional bronchodilation, avoiding the need for multiple inhalers.”
Trelegy Ellipta combines an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA). The combination is to be delivered daily once through GSK’s Ellipta dry powder inhaler.
According to GSK, the proposed strengths of the combined drugs in Trelegy Ellipta are 100mcg of fluticasone furoate, 62.5mcg of umeclidinium and 25mcg of vilanterol.
A positive opinion from CHMP is one of the last steps before a new therapy gets its marketing authorisation from the European Commission (EC). The final decision on approval of the FF/UMEC/VI single inhaler triple therapy by the EC is likely to come by the year end.
Innoviva CEO 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.”
In another development, GSK secured a positive opinion from CHMP for self-injectable formulation of Benlysta (belimumab) as an add-on therapy for systemic lupus erythematosus.
The recommendation from CHMP for Benlysta is for adult patients with active autoantibody-positive SLE who have a high degree of disease activity in spite of getting standard treatment.
Image: GSK House in Brentford, London. Photo: courtesy of GlaxoSmithKline plc.
