GSK receives positive CHMP opinion for Incruse® (umeclidinium) for the treatment of COPD

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium under the proposed brand name Incruse® as a once-daily, maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Umeclidinium is an investigational long-acting muscarinic antagonist (LAMA). The proposed strength is 55mcg inhalation powder contained in the Ellipta® inhaler.

Patrick Vallance, GSK’s President of Pharmaceuticals R&D, said, “GSK is committed to the development of a range of respiratory medicines that allow physicians to make treatment choices based on their individual patients’ needs. The CHMP’s decision brings us a step closer to offering physicians a further once-daily treatment choice for appropriate COPD patients. We look forward to a final decision from the European Commission in the next few months.”

A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission. A final decision by the European Commission is anticipated during the second quarter of 2014.

The EMA assessment of umeclidinium included a review of seven Phase 3 clinical trials which included over 2,500 COPD patients treated with umeclidinium or placebo. These trials included a number of studies from the clinical development programme designed to investigate umeclidinium used as monotherapy and also in combination with the investigational long-acting beta2 agonist, vilanterol. The investigational combination therapy is currently undergoing regulatory review under the proposed brand name Anoro® (umeclidinium/vilanterol).