GlaxoSmithKline’s (NYSE: GSK) Relovair, a respiratory drug candidate, will have drug applications filed in Europe and the United States this year despite mixed trial results comparing the compound to Advair, the GSK drug Relovair is intended to replace.
GSK and drug partner Theravance (Nasdaq: THRX) released topline results from two phase 3 studies for chronic obstructive pulmonary disorder. Relovair was developed to offer once-a-day dosing, an advantage compared to twice-a-day Advair. In earlier clinical studies, Relovair showed no statistical significance compared to Advair.
In the study results released today, Relovair was better than Advair in one study. But in a second study, Relovair showed numerical improvement but not statistical superiority compared to Advair. In an study of Relovair as an asthma treatment, the drug candidate showed statistically significant results compared to placebo.
Britain-based GSK, which has its U.S. headquarters in Research Triangle Park, said drug applications for Relovair in the COPD indication will be filed in the United States and Europe in mid-2012. An application for the compound in asthma is planned for mid-2012 in Europe.
GSK said it will continue to to discuss with the U.S. Food and Drug Administration an asthma indication for the compound in the United States.