Incruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.
Currently licensed across all EU member states, Incruse is a 55mcg strength inhalation powder delivered by the Ellipta inhaler.
GSK SVP and head of Global Respiratory Franchise Darrell Baker said COPD affects millions of people in Europe and for many years the company has been committed to researching and improving understanding of it.
"We are delighted by today’s marketing authorisation for Incruse Ellipta, our first LAMA, which will provide healthcare professionals with a further treatment option for appropriate COPD patients," Baker said.
"This is in line with our goal to develop a range of respiratory medicines that allow physicians to make treatment choices based on their individual patients’ needs."
The company expects to launch the product in Europe by the end of 2014.
The EMA evaluation of umeclidinium included a review of seven Phase III clinical trials which included over 2,500 COPD patients treated with umeclidinium or placebo.
In these trials about 576 patients received the recommended dose of umeclidinium 55mcg once-daily.
Image: GlaxoSmithKline headquaters in London. Photo: Courtesy of Maxwell Hamilton