According to GlaxoSmithKline, the company has submitted an application to the FDA for umeclidinium bromide (UMEC) administered using the Ellipta DPI for the treatment of COPD. The filing comes just days after GSK announced the submission of an MAA in Europe for UMEC monotherapy. The company says that it plans additional filings for the product this year.
GSK and Theravance has also submitted applications for UMEC/vilanterol combination therapy, to be marketed as Anoro Ellipta, this year in the US, in Europe, and in Japan.
Read the GSK press release.
