Shortly after announcing that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According to GSK, the product would be marketed as “Incruse” and would deliver a 55 mcg dose of UMEC via the Ellipta dry powder inhaler.
GSK President of Pharmaceuticals R&D Patrick Vallance commented, “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.”
GSK submitted the marketing authorization application for UMEC monotherapy in April 2013 and announced the submission of an NDA for the product a few days later.
Read the GSK press release.
