GlaxoSmithKline and Theravance say that they have submitted an NDA to the US FDA for an umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD to be marketed under the name “Anoro Ellipta.” The LAMA/LABA combination is a once-daily treatment.
According to the companies, they plan regulatory filings for UMEC/VI in the European Union “imminently,” and submissions are planned for additional countries in 2013. GSK says that it will submit applications worldwide for a UMEC-only DPI using the Ellipta inhaler in 2013 as well.
Read the GSK/Theravance press release.
