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Trials & Filings

GSK, Theravance Post Good Asthma Data

FF/VI shows strong results

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

GlaxoSmithKline and Theravance has posted positive results from a Phase III efficacy and safety study of fluticasone furoate/vilanterol (FF/VI) designed to support a potential filing for an asthma indication for adults in the U.S. FF/VI is approved in the U.S. for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations, FF/VI is not an FDA-approved treatment for asthma.

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 at the end of the 12-week treatment period. In patients receiving FF/VI 200/25mcg, an additional improvement of 24ml was observed when compared with FF/VI 100/25mcg. These results will inform GSK’s discussions with the FDA on the regulatory requirements of an asthma indication for FF/VI in the U.S.

The study is a 12 week, double-blind, parallel group, multicenter study to assess the efficacy and safety of FF/VI 200/25mcg inhalation powder, FF/VI 100/25mcg inhalation powder and FF 100mcg inhalation powder, evaluating 990 patients with moderate to severe persistent asthma. 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.

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