Edoxaban Review ‘Not About Comparative Efficacy,’ FDA Says
Structured benefit/risk framework requires consideration of current treatment options, agency says in asking its cardio-renal advisory committee to consider the existence of three other novel anticoagulants when weighing the poor efficacy seen with Daiichi’s Factor Xa inhibitor in a large patient subgroup.
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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.
FDA recommends head-to-head studies against already marketed products – an unusual development policy for the agency.
The Japanese pharma scored an approval of its oral anticoagulant, but is at a disadvantage to competition due to a label that restricts use to patients with renal impairment.