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Once-daily single inhaler triple therapy receives positive opinion for appropriate patients with COPD

GlaxoSmithKline and Innoviva, Inc have  announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI) as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

Trelegy Ellipta is a combination of an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-adrenergic agonist (LABA), delivered once daily in GSK’s Ellipta dry powder inhaler. It is the first once-daily single inhaler triple therapy to be granted a positive opinion by the CHMP. The proposed strength is FF/UMEC/VI 100/62.5/25 mcg.

Patrick Vallance, GSK’s President, R&D, 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.”

Mike Aguiar, CEO of Innoviva, Inc. 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 CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated by around the end of 2017.

Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the US, Australia and Canada. FF/UMEC/VI is an investigational medicine not yet approved for use as a single inhaler triple therapy anywhere in the world. The proposed trade name ‘Trelegy Ellipta’ is subject to regulatory approval.