Portola Pharmaceuticals' Bevyxxa drug was approved by the U.S. Food and Drug Administration for treating adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complication.
"Bevyxxa represents a major advance for the field of thrombosis. It is the first therapy to demonstrate a reduction in the incidence of VTE in these high-risk patients without a significant increase in major bleeding,” Dr. C. Michael Gibson, chair of the PERFUSE study group, said in a statement. “With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition,” Gibson said.
Bevyxxa is an oral, once-daily Faxtor Xa inhibitor that was granted fast track designation by the FDA and was approved as part of the FDA’s priority review system.
“Our goal as a company is to bring to market important medicines for the benefit of patients,” Portola CEO Bill Lis said. “Today’s approval is the ultimate milestone for Portola. We are grateful to the patients who participated in our trials, the FDA, our academic collaborators and investigators, and, importantly, our dedicated employees who have worked tirelessly to achieve this goal.”
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