FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Bevyxxa (betrixaban)

Indication:

Venous thromboembolism (VTE) prophylaxis in adults hospitalized for acute medical illness who are at risk for thromboembolic complications owing to moderate or severe restricted mobility and other risk factors for VTE.

Mechanism:

Oral FXa inhibitor resulting in decreased thrombin formation in the coagulation cascade.

Dosage:

160 mg PO once, then 80 mg/day for 35-42 days. Dosage modification needed if coadministered with P-gp inhibitors or severe renal impairment.

Approval:

Approval was based on data from the phase 3 APEX studies. These clinical trials found betrixaban showed significant decreases in VTE events compared with enoxaparin.

References:

Cohen AT, et al. Extended thromboprophylaxis with betrixaban in acutely ill medical patients. N Engl J Med. 2016 Aug 11;375(6):534-44.

Gibson CM, et al. Extended-duration betrixaban reduces the risk of stroke versus standard-dose enoxaparin among hospitalized medically ill patients: an APEX trial substudy (acute medically ill venous thromboembolism prevention with extended duration betrixaban). Circulation. 2017 Feb 14;135(7):648-655.

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