GSK and Theravance have submitted a supplemental New Drug Application (sNDA) to the FDA for the Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment of asthma in patients 12 years old and older, the companies announced.
The FDA approved Breo Ellipta 100/25mcg for the treatment of COPD in May 2013. The approval of Breo Ellipta for asthma required a boxed warning about the increased risk of asthma-related deaths associated with the use of LABAs. In Europe, where the product is called Relvar Ellipta, the FF/VI inhaler is approved for both COPD and asthma for certain patients.
The sNDA requests approval of both the 100/25mcg DPI and a 200/25mcg version. GSK and Theravance are citing positive results from a Phase 3 study of both doses in patients with severe asthma that were announced in December 2013.
Read the GSK/Theravance press release.
