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First once-daily single inhaler triple therapy to be approved in Europe

GlaxoSmithKline and Innoviva, Inc have announced that the European Commission has granted marketing authorisation for Trelegy Ellipta (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 the first once-daily single inhaler triple therapy to be approved in Europe. It 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. The licensed strength as delivered is FF/UMEC/VI 92/55/2 mcg.

Eric Dube, Senior Vice President & Head, GSK Global Respiratory Franchise, said, “COPD is a serious lung disease that affects millions of people. Its progressive nature means symptoms can worsen over time with many patients also experiencing frequent debilitating exacerbations. A combination of different types of medicines can be required to achieve treatment goals. Trelegy Ellipta is the first medicine to be approved in Europe that delivers three effective molecules in a once-daily single inhalation. We believe this is an important innovation in COPD management and look forward to making it available for appropriate patients with COPD.”

Mike Aguiar, CEO of Innoviva, Inc. said, “Knowing that appropriate COPD patients will require triple therapy, Trelegy Ellipta affords the convenience of administration of three classes of medicines in a single inhaler. Having all three major classes of combination medication (ICS/LABA, LAMA/LABA, and now single inhaler triple therapy) in the single Ellipta inhaler is an important advance in inhaled therapeutics.”

The first European launch is expected to take place before the end of 2017.