FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

GSK/Innoviva’s COPD Inhaler Gets Expanded Indication in EU

Nov. 20, 2018

GlaxoSmithKline and Innoviva’s once-daily Trelegy Ellipta medication for chronic obstructive pulmonary disease (COPD) was approved for expanded use in the EU.

The EU approval makes Trelegy Ellipta the first single inhaler triple therapy indicated for patients with moderate to severe COPD not adequately treated with dual bronchodilation or with an inhaled corticosteroid and long-acting β2-agonist.

The expanded indication was based on a landmark study that showed the combination drug to be superior to other treatments on multiple significant endpoints, including improved lung function and health related quality of life.

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