EU Approval Recommended for Edoxaban for Stroke, Systemic Embolism in AF Patients

Deborah Brauser

April 24, 2015

LONDON, UK – The new oral anticoagulant edoxaban (Lixiana, Daiichi Sankyo) has received approval recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for use in the prevention of stroke and systemic embolism in patients with nonvalvular AF, as well as for prevention and treatment of recurrent venous thromboembolism[1].

CHMP is recommending marketing authorization for the medication, which will be available as film-coated tablets in doses of 15, 30, and 60 mg. Edoxabin is a factor Xa inhibitor, reducing the generation of thrombin and delaying clotting time.

CHMP reports that soft tissue hemorrhage is the most common treatment-related adverse event, followed by epistaxis and vaginal hemorrhage. "Bleeding can occur at any site and may be severe and even fatal," warns the agency, adding that anemia, rash, and abnormal liver-function tests are other common side effects.

The full indication notes that it should be used for stroke and systemic embolism in nonvalvular AF patients with congestive heart failure, diabetes, or hypertension who are older than 74 years or who had a transient ischemic attack or stroke previously; and for treatment and prevention in patients with pulmonary embolism (PE) and deep vein thrombosis (DVT).

In January of this year, as reported by heartwire from Medscape, the US Food and Drug Administration (FDA) also approved edoxaban (Savaysa) to reduce risk of stroke and systemic embolism in patients with nonvalvular AF and to treat DVT and PE. Its approval was based on results from the ENGAGE AF-TIMI 48 trial, which showed that the medication was noninferior to warfarin.

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