New Drug Evaluation : Drugs Essay

939 Words Apr 9th, 2015 4 Pages
Savaysa® (Edoxaban)
New Drug Evaluation

Manufacturer:
Daiichi Sankyo

Drug Class:
Anticoagulant (Factor Xa Inhibitor)

Pharmacology:
Edoxaban is a selective inhibitor of factor Xa, which inhibits prothrombinase activity to result in prevention of the conversion of prothrombin to thrombin, inhibition of subsequent thrombin-induced platelet aggregation, and suppression of resultant thrombus formation.

Pharmacokinetics:
Edoxaban has a half-life of 10 to 14 hours, a time to peak of 1 to 2 hours, a mean absolute bioavailability of 62%, and a volume of distribution of 107 liters. It undergoes moderate protein binding (approximately 55%) and is minimally metabolized (less than 10%) via hydrolysis and CYP3A4 conjugation and oxidation. The parent drug and predominant metabolite (M-4) are both excreted in the urine, with a clearance approximately 50% that of total body clearance.

Clinical Trials:
ENGAGE AF-TIMI 48
ClincalTrials.gov Identifier: NCT00781391
Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48
This Phase 3 clinical trial demonstrated the non-inferiority of edoxaban in comparison to warfarin for the prevention of stroke and thromboembolism in approximately 20,500 patients with atrial fibrillation.
Ruff CT, Giugliano RP, Antman EM, et al. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective…

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