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.

Agency staff recommend separate assessment of ischemic and hemorrhagic strokes, and exposure-targeting of therapeutic blood levels; cardio-renal panel endorses Daiichi Sankyo’s Factor Xa inhibitor for atrial fibrillation, but concerns about reduced efficacy in normal renal function patients may result in a competitively disadvantaged label.

Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.