|U.S. FDA Approves Bevyxxa® (betrixaban) First and Only Anticoagulant for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients|
Bevyxxa, an oral, once-daily Factor Xa inhibitor, was granted a Fast Track designation and approved by the
"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,” said
“Our goal as a company is to bring to market important medicines for the benefit of patients,” said
Acutely ill medical patients are those hospitalized for serious medical conditions, including heart failure, stroke, infection and pulmonary disease. Because of their underlying disorder and immobilization, they are at increased risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots.
In the G7 countries, an estimated 24 million acutely ill medical patients are hospitalized each year and are at risk of VTE, either while in the hospital or following discharge. More than one million VTE events and 150,000 VTE-related deaths occur annually in acutely ill medical patients in the G7 countries, despite the standard use of injectable enoxaparin and other heparins in the hospital. More than half of VTE events occur after patients are discharged from the hospital. No other anticoagulant, including enoxaparin or any of the marketed oral Factor Xa inhibitors, is approved for in-hospital and extended-duration VTE prophylaxis in acutely ill medical patients.
The APEX study evaluated oral betrixaban for 35 to 42 days compared with injectable enoxaparin for 6 to 14 days followed by placebo in assessing the prevention of VTE in high-risk acutely ill medical patients. As detailed in the prescribing information, Bevyxxa efficacy was measured in the modified Intent-to-Treat (mITT) analysis, which includes 7,441 patients assessed by a composite outcome score comprising either the occurrence of asymptomatic proximal DVT or symptomatic DVT, non-fatal PE or VTE-related death. Bevyxxa reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent; relative risk 0.75, 95 percent CI: 0.61, 0.91) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent). The most frequent reason for treatment discontinuation was bleeding, with an incidence rate for all bleeding episodes of 2.4 percent and 1.2 percent for betrixaban and enoxaparin, respectively.
Results from the APEX Study have been peer-reviewed and published in
“For the first time, physicians will have a therapy to help reduce VTE in acutely ill medical patients during their transition from hospital to home, which may ultimately help reduce morbidity,” said
The timeline on which Portola expects to launch Bevyxxa is between August and
In the EU, the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) is reviewing the Marketing Authorization Application for betrixaban under its standard review period.
BEVYXXA INDICATION AND USE
The recommended dose of Bevyxxa is an initial single dose of 160 mg starting on day 1, followed by 80 mg once daily taken for 35 to 42 days at the same time each day with food.
Limitations of Use
IMPORTANT SAFETY INFORMATION FOR BEVYXXA
Warning: Spinal / Epidural Hematoma
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement. Discontinue Bevyxxa in patients with active pathological bleeding. There is no established way to reverse the anticoagulant effect of betrixaban, which can be expected to persist for at least 72 hours after the last dose.
Spinal/Epidural Anesthesia or Puncture
Use in Patients with Severe Renal Impairment
Use in Patients on Concomitant P-glycoprotein (P-gp) Inhibitors
USE IN SPECIFIC POPULATIONS
For additional information and full Prescribing Information for Bevyxxa, please visit http://www.bevyxxa.com
1 Cohen, Alexander T.,