GlaxoSmithKline and Theravance have submitted a marketing application to the EMA for their umeclidinium bromide (UMEC)/vilanterol (VI) dry powder inhaler for the treatment of COPD. The product, which is delivered using the Ellipta DPI, would be marketed as Anoro. The two companies submitted an NDA to the FDA for UMEC/VI in December 2012.
The MAA is for 55/22mcg and 113/22mcg delivered doses; the NDA is for the equivalent pre-dispensed 62.5/25mcg and 125/25mcg doses.
Submissions to other countries are expected by the end of the year, and GSK says that it will also submit applications for UMEC monotherapy in 2013.
Read the GSK/Theravance press release.
