CHMP grants positive recommendation for Trelegy ( fluticasone furoate/ umeclidinium/vilanterol (FF/UMEC/VI)) as a maintenance treatment for COPD.- GSK.
GlaxoSmithKline plc and Innoviva, Inc. 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. 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.
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