EU approves Incruse Ellipta for COPD-GSK
GlaxoSmithKline has announced that the European Commission has granted marketing authorisation for Incruse (umeclidinium) powder delivered by the Ellipta inhaler, as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with Chronic Obstructive Pulmonary Disease (COPD).
The EMA assessment of umeclidinium included a review of seven Phase III clinical trials which included over 2,500 COPD patients treated with umeclidinium or placebo. Within this, 576 patients received the recommended dose of umeclidinium 55mcg once-daily. It is expected that the first launches will have taken place in Europe by the end of 2014.
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