Fluticasone/vilanterol combination (GSK) is filed in US for COPD and in the EU for Asthma and COPD

GSK and Theravance announced the submission of regulatory applications in the US and European Union for the once-daily investigational medicine Relovair( fluticasone furoate /vilanterol).

In the European Union the application is for patients with Chronic Obstructive Pulmonary Disease (COPD) and an application for Asthma. The Marketing Authorisation Application for the European Union for the combination has a new proposed brand name Relvar and will be administered by a new dry powder inhaler called Ellipta and was submitted to the European Medicines Agency for the regular treatment of asthma in adults and adolescents aged 12 years and older, where use of a combination product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate and for the symptomatic treatment of patients with COPD with a FEV1 <70% predicted normal (post-bronchodilator) in patients with an exacerbation history.>

In the US, the New Drug Application for the combination with the proposed brand name Breo, administered by the Ellipta inhaler, has been submitted to the FDA, for the 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.