GlaxoSmithKline says that it has submitted a Marketing Authorisation Application (MAA) to the EMA for umeclidinium bromide (UMEC) monotherapy to be delivered using the Ellipta DPI for the treatment of COPD. UMEC is a long-acting muscarinic antagonist (LAMA).
GSK and Theravance recently submitted an application in Japan for the Anoro Ellipta UMEC/vilanterol inhaler, and the two companies had earlier submitted applications for the combination therapy in the US and in Europe.
According to GSK, “Regulatory filings for UMEC monotherapy are imminent in the US and planned in other countries during the course of 2013.”
Read the GSK press release.
