(RTTNews) - GSK plc (GSK) on Friday said the European Commission has approved Nucala as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD).
The approval is based on results from the Phase III MATINEE trial, in which Nucala demonstrated a clinically meaningful and statistically significant reduction in the annualised rate of moderate to severe COPD exacerbations compared with placebo.
According to GSK, Nucala is the first biologic with pre-specified Phase III data to show a reduction in exacerbations leading to emergency department visits and/or hospitalisation versus placebo.
COPD affects more than 390 million people worldwide, including around 40 million in Europe.
On Thursday, GSK shares gained 3.39% before closing at $59.17.
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