LIXIANA® (edoxaban) for Stroke and Systemic Embolism in Patients with AF Receives Final Appraisal Determination (FAD) from NICE

LIXIANA® (edoxaban) for Stroke and Systemic Embolism in Patients with AF Receives Final Appraisal Determination (FAD) from NICE

Daiichi Sankyo’s once-daily LIXIANA® q (edoxaban) recently received a National Institute for Health and Care Excellence (NICE) Final Appraisal Determination (FAD) that recommends it as a novel preventive treatment against strokes and systemic embolism in patients with non-valvular atrial fibrillation.

The draft guidance states: “Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation with one or more risk factors, including:

  • congestive heart failure
  • hypertension
  • diabetes
  • prior stroke or transient ischaemic attack
  • age 75 years or older.

It adds: “The Committee concluded that taking all of the analyses into account, edoxaban was cost effective compared with warfarin and could be recommended as an alternative to warfarin for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation who have one or more risk factors for stroke.”

Edoxaban, a blood-thinner, is a Novel Oral Anti-Coagulant (NOAC), which refers to a classification of drugs that can be used in place of warfarin – a frequently prescribed drug that entails stringent treatment monitoring and avoidance of many food and medication interactions.

Professor Martin Cowie, Professor of Cardiology at Imperial College London and a noted researcher into AF, said edoxaban gave doctors the ability to better tailor medicines to individual patients. “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 spoilt for choice with modern blood-thinning drugs that do not need INR monitoring and are easy for patients to live with.”

It was June 2014 when NICE released an amended guideline on the management of atrial fibrillation, which updates the original publication dated 2006. According to the 2014 revision, England alone is home to 835,000 people with AF, and estimates show there may be at last 250,000 who remain undiagnosed. These numbers bring the prevalence of AF in England to 1 in every 50.

This recent NICE approval follows Edoxaban’s successful receipt of European marketing authorization for the following indications: Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Dr. Simon Clough, UK Managing Director for Daiichi Sankyo, said: “We are very pleased to be able to offer patients and doctors in England and Wales a new convenient to use alternative in the treatment armoury against AF-related illness. It is extremely gratifying that we have received NICE FADs for both AF and VTE within a very short time after gaining European authorisation.”

Dr. Clough added: “NICE has recognised an unmet clinical need among patients with AF and this recommendation confirms the value of edoxaban, which combines convenience and safety with features compared to warfarin that patients and physicians appreciate.”

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