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 …show more content…
In addition, the documented clinical trials have demonstrated only non-inferiority of the drug in comparison to warfarin or parenteral anticoagulants. Although the drug is likely eligible for significant manufacturer-sponsored rebates, the ultimate purchase price is likely to be much greater than the aforementioned options, precluding any realizable cost benefits. As such, except in the case of widespread unavailability of comparative therapies, I believe the purchasing and utilization of the drug should be
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 …show more content…
In addition, the documented clinical trials have demonstrated only non-inferiority of the drug in comparison to warfarin or parenteral anticoagulants. Although the drug is likely eligible for significant manufacturer-sponsored rebates, the ultimate purchase price is likely to be much greater than the aforementioned options, precluding any realizable cost benefits. As such, except in the case of widespread unavailability of comparative therapies, I believe the purchasing and utilization of the drug should be