Savaysa (edoxaban) is a factor Xa inhibitor which was approved by the FDA in 2015. Savaysa has the following so-called “indications” or approved uses:
- To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; and,
- For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.
In relevant part, from a September 15, 2016 FDA letter to Daiichi-Sankyo, Inc.:
Prior Approval supplemental new drug application provides for changes to SAVAYSA prescribing information based on results of the Phase 1 trial DU176b-A-U158 that evaluated the effects of Prothrombin Complex Concentrate (PCCs) on reversing the pharmacologic activity of edoxaban tosylate. Sections 5.3 ‘Risk of Bleeding’ and 12.2 ‘Pharmacodynamics’ have been updated to include this information.
For some related news as regards the FDA and Savaysa, see this article, “Xarelto / Savaysa / Eliquis: Antidote Drug AndexXa Is Rejected By FDA In August 2016“, over at our Drug Injury Watch blog.
We will continue to monitor the safety profile of Savaysa as well as Eliquis and Xarelto, especially as regards the current lack of any FDA-approved antidote which would act as a reversal agent for serious bleeding events such as intracranial hemorrhages or hemorrhagic strokes and gastrointestinal (GI) bleeds.
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