US approval for Portola’s BevyxXa

Portola Pharmaceuticals’ BevyxXa has been cleared by the US Food and Drug Administration for preventing blood clots in hospitalised patients.

The drug is the first and only anticoagulant for hospital and extended duration prophylaxis (35 to 42 days) of venous thromboembolism (VTE), in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors.

BevyXxa (betrixaban) is an oral, once-daily Factor Xa inhibitor approved by the FDA under a priority review and on the basis of findings from the Phase III APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide.

In the trial, the drug cut the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) blood clots compared with those taking enoxaparin plus placebo (4.4 percent vs. 6.0 percent) with no significant increase in major bleeding (0.67 percent vs. 0.57 percent).

"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 C. Michael Gibson, APEX executive committee member and steering committee chairman, professor, Harvard Medical School and chairman of the PERFUSE Study Group.

"With this approval, we are finally able to help protect these patients from this often fatal, yet preventable condition."

In the G7 countries, an estimated 24 million acutely ill medical patients are hospitalised 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 such patients, despite the standard use of injectable enoxaparin and other heparins in the hospital.

"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 Alexander (Ander) Cohen, APEX co-principal investigator and co-chairman of the APEX executive committee and consultant physician at Guy’s and St Thomas’ NHS Foundation.

Portola says it expects to launch BevyXxa between August and November this year while, across the pond, the drug remains under review in Europe.