GlaxoSmithKline (GSK) and Theravance, Inc. (THRX) posted positive results from a phase 3 study of its combination drug, Ellipta (FF/VI), as an asthma medication. The companies will use the data in meetings with the U.S. FDA to determine the regulatory requirements the companies will need to get approval for an asthma indication.
Ellipta is approved in the U.S. for patients with chronic obstructive pulmonary disease (COPD). FDA approval for asthma expands the market potential considerably.
Ellipta consists of ICS fluticasone furoate (FF) and the long-acting beta2 agonist (LABA) vilanterol (VI), as FF/VI and is administered via a dry powder inhaler (DPI) called Ellipta. It was approved by the U.S. FDA in May 2013 for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and / or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.
The study was a 12-week, double-blind multicenter study in 990 patients with moderate to severe persistent asthma. The trial assesses the efficacy and safety of two different doses of Ellipta (FF/VI 200/25mcg inhalation powder, FF/VI 100/25mcg inhalation powder) against FF alone. Patients were randomized to one of the three treatments taken once-daily in the evening. The primary endpoint was weighted mean serial FEV1 at the end of the 12-week treatment period. The primary comparison was FF/VI 100/25mcg versus FF 100mcg.
For the pre-specified primary endpoint of 0-24 hour weighted mean forced expiratory volume in one second (FEV1), FF/VI 100/25mcg demonstrated a statistically significant improvement in lung function compared with FF 100mcg (108ml, 95% CI 45, 171 p). GSK will use the results of this study to discuss regulatory requirements with the FDA for an asthma indication.
