GSK/Theravance apply for U.S. approval of once-daily asthma treatment
- GSK/Theravance have filed a supplemental NDA for a fixed-dose combo of fluticasone furoate (inhaled corticosteroid) and vilanterol. The treatment is marketed as Breo Ellipta.
- Breo Ellipta (FF/VI) is currently approved for long-term, once-daily treatment of airflow obstruction and for reduction of exacerbations in patients with chronic obstructive pulmonary disease.
- The sNDA seeks approval to expand use of FF/VI to include once-daily treatment of asthma. The clinical data set to support this application is very extensive and strong.
Since May 2013, FF/VI has been approved as Breo Ellipta in a 100/25 mcg fixed-dose combination; however the sNDA that GSK and Theravance have submitted seeks approval for two doses of FF/VI, including the 100/25 mcg formulation, as well as a 200/25 mcg formulation. If approved for the once-daily treatment of asthma, Breo Ellipta will be marketed to patients aged 12 and older.
The clinical data used to support the application is comprehensive. It includes 48 clinical pharmacology studies in 1,328 subjects and 23 clinical studies in 12,051 patients with asthma.
- Pharmaceutical Business Review GSK, Theravance submit sNDA to FDA for fluticasone furoate/vilanterol to treat asthma