GlaxoSmithKline plc and Innoviva 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 (for effects on symptom control see section 5.1). The proposed brand name is Trelegy Ellipta.
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.