GlaxoSmithKline and Theravance withdraw Japan NDA for Relvar Ellipta in COPD

UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) revealed on Friday (July 12) that they have withdrawn their current Japanese New Drug Application (JNDA) for the use of fluticasone furoate (FF) and vilanterol (VI) (proposed brand name Relvar Ellipta) in patients with chronic obstructive pulmonary disease (COPD).

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 combination was approved for the treatment of COPD by the US Food and Drug Administration, under the trade name Breo Ellipta, earlier this year (The Pharma Letter May 13).

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 six-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.