Breo Ellipta fluticasone furoate/vilanterol regulatory update

FDA approved an sNDA for Breo Ellipta fluticasone furoate/vilanterol from GlaxoSmithKline and Theravance as a once-daily maintenance treatment for asthma in adults. The agency issued a complete response letter for the product’s use in patients aged 12-17. According to the partners, FDA requested additional data in the age group. Breo Ellipta is approved in the U.S. for maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). The product is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting adrenergic receptor beta 2 agonist (LABA) vilanterol administered with the dry powder Ellipta inhaler. ...