GSK receives EU marketing authorisation for Incruse (umeclidinium) for the treatment of COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the European Commission has granted marketing authorisation for Incruse^® (umeclidinium) as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Now licensed across all EU member states, Incruse is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic. Incruse is a 55mcg strength inhalation powder delivered by the Ellipta^® inhaler.

Darrell Baker, SVP & Head, GSK Global Respiratory Franchise, said, “COPD affects millions of people in Europe and for many years we have 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. 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.”

It is expected that the first launches will have taken place in Europe by the end of 2014.

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.

For the EU Summary of Product Characteristics for Incruse, please visit http://ec.europa.eu/health/documents/community-register/index_en.htm. Prior to the label being posted online, a copy of the label may be requested from one of the GSK Media or Investor Relations contacts listed in the “GSK Enquiries” section at the end of this document.