Portola Pharmaceuticals, Inc.® (NASDAQ: PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Prior Approval Supplement (PAS) for Bevyxxa® (betrixaban) ahead of its scheduled January 30th action date, allowing for the release and distribution of its current product inventory. The Company plans to initiate commercial launch in early January 2018 and will provide an update during the next investor presentation and webcast, scheduled for Tuesday, January 9 (7:00 am PT/10:00 am ET).
“We are pleased to be able to make Bevyxxa available to acute medically ill patients at high risk of venous thromboembolism beginning in January 2018,” said Bill Lis, chief executive officer of Portola. “VTEs result in approximately 100,000 deaths annually in the U.S. in acute medically ill patients – and they are preventable. As the first and only anticoagulant approved as a single-drug regimen administered in the hospital and following discharge for a treatment duration of 35-42 days, Bevyxxa has the potential to impact public health in the U.S. and beyond, if approved in other countries. We thank the FDA for its guidance throughout the review process and look forward to continuing our collaborative efforts with the agency for the benefit of patients.”
Bevyxxa was approved by the FDA on June 23, 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 hospitalized 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.
Important U.S. Safety Information for Bevyxxa (betrixaban) capsules
INDICATION Bevyxxa is indicated for the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized 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.
LIMITATIONS OF USE The safety and effectiveness of Bevyxxa have not been established in patients with prosthetic heart valves because this population has not been studied.