NICE Recommends Edoxaban for Preventing Stroke and Systemic Embolism in NVAF Patients

August 7, 2015—Daiichi Sankyo Company, Ltd. announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) issued a Final Appraisal Determination (FAD) for the company’s Lixiana (edoxaban) for preventing stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).

The draft guidance advised that edoxaban is recommended, within its marketing authorization, as an option for preventing stroke and systemic embolism in adults with NVAF with one or more risk factors, including congestive heart failure, hypertension, diabetes, previous stroke or transient ischemic attack, and age 75 years or older. The FAD recommends that edoxaban, a novel oral anticoagulant used as an alternative to warfarin, is a cost-effective use of the National Health Service’s resources for this indication.

The FAD stated, “The committee concluded that edoxaban was as clinically effective as warfarin for the primary efficacy outcome of reducing stroke (ischemic and hemorrhagic) and systemic embolism and had nearly half the rate of hemorrhagic stroke events compared to warfarin.”

Prof. Martin Cowie, Professor of Cardiology at Imperial College London, commented in the company’s press release, “A few years ago, all we had to prevent strokes in AF patients was warfarin, which imposes many lifestyle restrictions on patients and needs monitoring with a blood test system known as INR. Now we are spoiled for choice with modern blood-thinning drugs that do not need INR monitoring and are easy for patients to live with.”

On July 13, NICE issued an FAD for edoxaban for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults. The NICE approval also follows the recent European marketing authorization or edoxaban for two indications: (1) treatment of DVT and PE and prevention of recurrent DVT and PE in adults; and (2) prevention of stroke and systemic embolism in adult patients with NVAF with one or more of the previously noted risk factors, noted Daiichi Sankyo.