Betrixaban failed to meet its primary endpoint in a patient subgroup of the APEX trial, but overall results look encouraging.
By Nitesh Singhvi, Analyst
27 April 2016
Betrixaban failed to demonstrate statistical significance in the primary efficacy analysis of cohort 1 patients in its Phase III APEX trial, but the results from cohort 2 and the overall study population look encouraging. Datamonitor Healthcare predicts that approval of the drug remains uncertain owing to its mixed performance in the APEX study, but positive overall results will help to increase the likelihood of approval.
The overall topline results from the APEX study are superior to the study results from other NOAC drugs studied in the critically ill patient segment. In addition, betrixaban demonstrated a lower relative risk of recurrent VTE and overall bleeding events when compared to Xarelto (rivaroxaban; Bayer/Johnson & Johnson) and Eliquis (rivaroxaban; Bristol-Myers Squibb/Pfizer), which will help in increasing betrixaban’s chances of getting approved in this patient segment
|Primary efficacy analysis (recurrent VTE)||Primary safety analysis (major bleeding)|
|Relative risk||p-value||Relative risk||p-value|
|Cohort 1: Elevated D-Dimer||0.806||0.054||0.88||0.722|
|Cohort 2: Elevated D-Dimer or Age >75||0.800||0.029||1.19||0.564|
|Overall Study Population||0.760||0.006||1.19||0.554|
Source: Portola news release, 2016
This is excerpted from Datamonitor Healthcare’s VTE: Pipeline, exploring the potential VTE therapies currently under development and their impact on the VTE treatment market after their approval.
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