GlaxoSmithKline and Theravance have withdrawn the application for their fluticasone furoate/vilanterol DPI for the treatment of COPD from the Japanese New Drug Application (JNDA) for the drug, the companies say. Review of the JNDA, which was submitted in September 2012, will continue for the FF/VI combination inhaler for the treatment of asthma. If approved, the inhaler will be called Relvar Ellipta in Japan.
According to the companies: “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.”
Additional clinical studies with Japanese COPD patients are a possibility, the companies said, adding that “Further details will be provided in due course.”
Read the GSK and Theravance press release.
