GlaxoSmithKline, Theravance Withdraw License Application for RELVAR ELLIPTA in Japan

GlaxoSmithKline (GSK) and Theravance, Inc.

today announced that the licence application for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name RELVAR™ ELLIPTA™) in patients with chronic obstructive pulmonary disease (COPD) has been withdrawn from the current Japanese New Drug Application (JNDA). The review of FF/VI for use in patients with asthma is continuing to progress through the normal Japanese regulatory process as part of this JNDA. The submission for the once-daily investigational medicine FF/VI contained data from six studies in over 6,000 COPD patients. Japanese patient specific efficacy data were generated from two 6-month efficacy (lung function) studies. These studies demonstrated the benefit of the combination FF/VI compared with placebo on the co-primary endpoints of 0-4 hour weighted mean FEV1 and trough FEV1. However, in an assessment of the contribution of each of the individual components, while VI achieved a statistically significant improvement in weighted mean FEV1 the contribution of FF on improvement of lung function did not achieve statistical significance in these studies. As no Japanese patients were enrolled in either of the 52-week exacerbation studies also conducted with FF/VI, GSK believes that the data from the 6-month studies alone may be insufficient to support the efficacy of the combination and its components in this specific patient group. As a result, a decision has been taken to withdraw COPD from the current JNDA at this time. The application for FF/VI as a potential treatment for asthma remains under review in Japan.