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Novel Anticoagulants Need Blood Level Monitoring Measures, FDA’s Temple Says

Executive Summary

Although coagulation level monitoring would negate the newer drugs’ convenience advantage over warfarin, FDA reviews of Daiichi’s Savaysa suggest a tailored dosing approach is needed to optimize antithrombotic benefits against bleeding risks.

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Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population

Reviewers debated whether to approve Daiichi’s oral anticoagulant only for atrial fibrillation patients with renal impairment or a higher-than-tested dose for those with normal renal function. Disagreements over how to handle renal subgroup efficacy findings also led to differences of opinion on the need for a REMS.

Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population

Reviewers debated whether to approve Daiichi’s oral anticoagulant only for atrial fibrillation patients with renal impairment or a higher-than-tested dose for those with normal renal function. Disagreements over how to handle renal subgroup efficacy findings also led to differences of opinion on the need for a REMS.

Savaysa Under-Dosing Not A Concern In DVT/PE Treatment

However, clinical pharmacology and hematology division reviewers differed on whether dose reductions were appropriate for patients of low body weight or using certain concomitant drugs.

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