Savaysa Under-Dosing Not A Concern In DVT/PE Treatment
Executive Summary
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.
You may also be interested in...
Savaysa Shows The Good And Bad Of Being Late In Class
As Daiichi’s experience suggests, sponsors of later-in-class products may face unfavorable efficacy comparisons to their earlier-approved brethren and challenges in qualifying for a priority review; however, risk management obligations may be less burdensome than for first-in-class products.
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.