BioCentury
ARTICLE | Company News

Portola submits NDA for betrixaban

October 25, 2016 7:00 AM UTC

Portola Pharmaceuticals Inc. (NASDAQ:PTLA) said it submitted an NDA to FDA for oral Factor Xa inhibitor betrixaban ( PRT054021) as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Betrixaban has Fast Track designation from FDA in the indication.

In March, Portola reported data from the Phase III APEX trial showing that betrixaban failed to show superiority to standard of care enoxaparin to prevent VTE in acute medically ill patients. The trial's design required that significant superiority be shown in the trial's first cohort in order to evaluate two larger cohorts sequentially. Betrixaban narrowly missed statistical significance in the first cohort. Despite the miss, Portola conducted an exploratory analysis showing that betrixaban met the superiority endpoint in the larger cohorts, including the overall study population (see BioCentury, April 4). ...