Portola soars on FDA approval

The US Food and Drug Administration on Friday approved Bevyxxa (betrixaban), sending the shares of the drug’s developer, Portola Pharmaceuticals (Nasdaq: PTLA), rocketing 46.56% to $56.06.

Bevyxxa thus becomes the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) 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.

Bevyxxa, an oral, once-daily Factor Xa inhibitor, was granted a Fast Track designation and approved by the FDA under Priority Review, which is a status given to drugs that may offer significant improvements in treatment or provide a treatment where no adequate therapy exists. Bevyxxa has been approved based on data from Portola's pivotal Phase III APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide.