Biotech Values

[DewDiligence]

Re: Apixaban vs Lovenox in VTE prevention

PFE/BMY are presumably going to submit an NDA for Apixaban in VTE prevention following hip or knee surgery, but this could be tricky because one of the two knee studies (ADVANCE-1) failed to show non-inferiority to Lovenox (#msg-31742223).

By combining the ADVANCE-2 study in knee surgery (#msg-47461590) with the ADVANCE-3 study in hip surgery (the study you just posted about), PFE/BMY may be able to persuade the FDA to use the pooled results for both hip and knee. However, there are also questions regarding the dose of Lovenox used in the comparator arms of these studies, as discussed in the prologue of #msg-47461590.