The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline (GSK)'s 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 III 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).

In April 2013, a New Drug Application (NDA) for umeclidinium monotherapy (62.5mcg) was submitted to the US Food and Drug Administration (FDA), under the trade name Incruse and is currently under review. The umeclidinium dose of 62.5mcg is specified as the pre-dispensed dose (contained inside the inhaler) which is equivalent to the 55mcg delivered dose (emitted from the inhaler) submitted for approval in Europe.

Umeclidinium is an investigational medicine and is not currently approved anywhere in the world.