Investment Research and Business Due Diligence
Wednesday, July 17, 2013
GSK withdraws application for approval for Relovair in COPD in Japan
GSK had earlier filed the combination for approval in
COPD and bronchial asthma on September 25, 2012 in Japan, but based on review by the authorities, it has decided to withdraw application for approval in COPD.
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.
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