GSK, Innoviva: Trelegy Ellipta Gets CHMP Positive Opinion In Europe For COPD

(RTTNews) - GlaxoSmithKline Plc (GSK.L, GSK) and Innoviva, Inc. (INVA) announced Friday that Trelegy Ellipta once-daily single inhaler triple therapy received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP for appropriate patients with chronic obstructive pulmonary disease or COPD.

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 COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist.

The proposed brand name is Trelegy Ellipta, a combination of an inhaled corticosteroid or ICS, a long-acting muscarinic antagonist and a long-acting beta2-adrenergic agonist, 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.

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.

The proposed trade name 'Trelegy Ellipta' is subject to regulatory approval.