NDA Submitted for Fluticasone Furoate/Vilanterol (FF/VI) for COPD
GlaxoSmithKline and Theravance announced the submission of a New Drug Application (NDA) to the FDA for the once-daily investigational medicine fluticasone furoate/vilanterol (FF/VI) for patients with chronic obstructive pulmonary disease (COPD).
The NDA for FF/VI, with the proposed brand name Breo, administered by the Ellipta inhaler, has been submitted for long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations.
Fluticasone furoate is a steroid. Vilanterol is a long-acting beta2 agonist.