Savaysa Clinical Development
Executive Summary
A timeline chronicling the development of Daiichi Sankyo’s Factor Xa inhibitor edoxaban for stroke risk reduction, deep vein thrombosis and pulmonary embolism indications.
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How Many People Can Squeeze Into A Mid-Cycle Meeting? For Savaysa, The Number Is 70
NDA’s complexity and a major efficacy review issue on the a-fib indication help explain the large contingent of FDA and sponsor participants in meetings required under the PDUFA V review ‘Program.’
Savaysa Couldn’t Get Two Indications Out Of One Trial
FDA may have taken the view that a single, 12-month study could not support approval of Daiichi’s anticoagulant for prevention of venous thromboembolism in addition to a treatment claim.
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.