GSK, Theravance Report Positive Results From Phase III Study For FF/VI In Asthma

(RTTNews) - GlaxoSmithKline Plc. (GSK, GSK.L) and Theravance Inc. (THRX) announced positive results from a phase III efficacy and safety study of fluticasone furoate "FF"/vilanterol "VI" designed to support a potential filing for an asthma indication for adults in the US.

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 < 0.001) at the end of the 12 week treatment period.

In patients receiving FF/VI 200/25mcg an additional improvement of 24ml (95% CI -37, 86) was observed when compared with FF/VI 100/25mcg.

Theravance said that the study meets primary efficacy endpoint.

While FF/VI is approved in the US for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease or COPD and to reduce exacerbations of COPD in patients with a history of exacerbations, FF/VI is not an FDA-approved treatment for asthma.

Theravance stated that the results will inform GSK's discussions with the FDA on the regulatory requirements of an asthma indication for FF/VI in the US.

The most common reported side effects across all treatment arms included headache, nasopharyngitis, upper respiratory tract infection and influenza.

The study is a 12 week, double-blind, parallel group, multicentre 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 randomised 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.