Friday, March 23, 2012

GSK and Thervance announce results from two non-pivotal Phase 3 studies comparing Relovair and Advair head to head

GSK and Thervance today announced that the registrational program for Relovair is complete. They also announced head to head data comparing Relovair with Advair in two non-pivotal Phase 3 studies. In one of the study, Relovair was found statistically significant superior to Advair in 0-24hr weighted mean FEV1 (P<0.001), while in another study Relovair showed numerical improvement, but not statistically significant.

GSK continues with its plans to submit regulatory applications for FF/VI in the US and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and will continue discussions with the FDA on the regulatory requirements for a US asthma indication