Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018.
Portola Pharmaceuticals today announced that the U.S. FDA has approved the Company’s Prior Approval Supplement (PAS) for Bevyxxa (betrixaban) ahead of its scheduled 30 January action date, allowing for the release and distribution of its current product inventory.
Bevyxxa was approved by the FDA on 23 June 2017 as a single-drug regimen in the hospital and following discharge for a treatment duration of 35-42 days for the prevention of VTE in adult patients hospitalised for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
