CHMP recommends approval of Incruse for COPD - GSK

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GSK 573719 (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). 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 treatment vilanterol. The investigational combination therapy is currently undergoing regulatory review under the proposed brand name Anoro. In April 2013, a New Drug Application for umeclidinium monotherapy was submitted to the FDA, under the trade name Incruse and is currently under review.