FDA approves Savaysa to treat Stroke Risk in patients with Atrial Fibrillation and for DVT and Pulmonary Embolism- Daiichi Sankyo
Daiichi Sankyo Company, Limited announced that the FDA has approved Savaysa (edoxaban) Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of Stroke and Systemic Embolism (SE) in patients with Non-Valvular Atrial Fibrillation (NVAF). In ENGAGE AF-TIMI 48, Savaysa was non-inferior to warfarin in the overall study population for the primary efficacy endpoint of stroke or SE. As stated in the U.S. label, Savaysa should not be used in NVAF patients with creatinine clearance (CrCL) levels greater than 95 mL/min because in that population there is an increased risk of ischemic stroke compared to warfarin. Patients with CrCL less than or equal to 95 mL/min represented 77% of the patients studied. In those patients, Savaysa 60 mg (30 mg dose reduced) reduced the risk of stroke and SE when compared to warfarin (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.55 to 0.84), and the rates of cardiovascular death with Savaysa and warfarin were 2.95% per year vs. 3.59% per year, respectively.
The FDA also approved Savaysa for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.
In the ENGAGE AF-TIMI 48 trial, Savaysa has been shown to reduce the risk of stroke and SE with significantly less major bleeding for patients with NVAF, and in the Hokusai-VTE trial, to treat DVT and PE with significantly less clinically relevant bleeding versus warfarin.
Comment:There are already three drugs competing to reduce the dominance of warfarin - two other factor Xa inhibitors, Bayer/Johnson & Johnson�s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb�s Eliquis (apixaban) and Boehringer Ingelheim�s oral direct thrombin inhibitor Pradaxa (dabigatran etexilate). The only truly obvious difference among them is that Eliquis and edoxaban are once-daily pills, while Pradaxa and Xarelto are taken twice daily.
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