Healthcare Industry News:  metabolic disease 

Biopharmaceuticals Cardiology Regulatory

 News Release - August 7, 2015

NICE Recommends Once-daily Lixiana(R) (Edoxaban) for Preventing Stroke and Systemic Embolism in People with Non-valvular Atrial Fibrillation

NICE Final Appraisal Determination recommends that edoxaban is a cost effective use of NHS resources

GERRARDS CROSS, England, August 7, 2015 -- (Healthcare Sales & Marketing Network) -- The National Institute for Health and Care Excellence (NICE) has recommended a new treatment to help prevent strokes and systemic embolism in patients suffering from the heart rhythm disorder atrial fibrillation.[1]

NICE has issued a Final Appraisal Determination (FAD) for Lixiana (edoxaban) for preventing stroke and systemic embolism in people 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The draft guidance states: "Edoxaban is recommended, within its marketing authorisation, as an option for preventing stroke and systemic embolism in adults with non-valvular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, made by the pharmaceutical company Daiichi Sankyo, is one of the class of blood-thinning drugs known as Novel Oral Anti-Coagulants (NOACs). The drugs are used as an alternative to warfarin, which has been widely used for over 50 years but requires frequent monitoring to ensure the drug is working properly and is also associated with many food or drug 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."

Non-valvular atrial fibrillation (AF) is a condition where the heart beats irregularly meaning blood can pool and thicken in the chambers of the heart, causing a risk of clots which then go on to cause strokes.[2]

In June 2014 the National Institute for Health and Care Excellence (NICE) published a revised guideline on the management of AF, updating its advice from its original guideline of 2006.[3]

The revised guideline said some 835,000 people in England alone have AF.[3]

In addition there may be another 250,000 people who are undiagnosed, according to a NICE press release issued to accompany the guideline.[4]

NICE put the prevalence of AF in England at 2% - one in 50 of the population.[3]

The NICE approval comes shortly after edoxaban received simultaneous European marketing authorisation for two indications:
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults
  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age = 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
NICE issued a FAD for edoxaban for the treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrent DVT and PE in adults, on 13 July this year.

The draft NICE FAD for edoxaban noted: "The Committee was aware that non-valvular atrial fibrillation is well-managed with warfarin for many people, but is associated with a number of problems including the need for regular monitoring and dose adjustment, and it has multiple food and drug interactions."

"The Committee accepted the limitations of warfarin therapy and the considerable impact it may have on people who take it, and recognised the potential benefits of edoxaban for people with non-valvular atrial fibrillation."

The FAD continued: "The Committee concluded that edoxaban was as clinically effective as warfarin for the primary efficacy outcome of reducing stroke (ischaemic and haemorrhagic) and systemic embolism, and had nearly half the rate of haemorrhagic stroke events compared to warfarin."

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."

The key clinical evidence for edoxaban in AF came from a global phase 3 study, called ENGAGE AF-TIMI 48. The study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with non-valvular atrial fibrillation (NVAF). This represents the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date, with a median follow-up of 2.8 years.[5]

NICE said the trial was of good quality, well designed and generalisable to clinical practice in the UK.

Resources for the media

To assist the media, UK-specific backgrounders are available on AF and edoxaban. See further information details to obtain these.

About AF

Non-valvular atrial fibrillation (AF) is a condition where the heart beats irregularly meaning blood can pool and thicken in the chambers of the heart, causing a risk of clots which then go on to cause strokes.[4]

Patients with AF are five times more likely to suffer a stroke than those without the condition.[6]

About Edoxaban

Edoxaban is an oral, once-daily, direct factor Xa (pronounced "Ten A") inhibitor. Factor Xa is one of the key components responsible for blood clotting, so inhibiting this makes the blood thin.

The ENGAGE AF-TIMI 48 global Phase 3 study investigated once-daily edoxaban in comparison to warfarin in 21,105 patients with non-valvular atrial fibrillation (NVAF). This represented the largest and longest trial with a novel anticoagulant in patients with atrial fibrillation performed to date, with a median follow-up of 2.8 years.[5]

Edoxaban demonstrated non-inferiority for stroke or systemic embolic events.[5]

Edoxaban was also found to be superior for the principal safety endpoint of major bleeding in comparison to warfarin.[5]

Appropriate use of Edoxaban

Haemorrhage is a common adverse effect of all anticoagulants.
  • Special care should be taken when deciding to prescribe edoxaban to patients with other conditions, procedures, and concomitant treatments, which may increase the risk of major bleeding.
  • As such, a detailed prescriber guide has been made available to HCPs to ensure correct use of the drug
  • In addition, every pack contains a patient alert card which can help alert treating HCPs in the case of routine or emergency interventions
The prescriber guide and a full list of contraindications, warnings and information on posology can be found in the edoxaban summary of product characteristics at https://www.medicines.org.uk/emc/medicine/30506

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 17,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to its strong portfolio of medicines for hypertension, dyslipidemia, bacterial infections, and thrombotic disorders, the Group's research and development is focused on bringing forth novel therapies in cardiovascular-metabolic diseases, pain management, and oncology, including biologics. For more information, please visit: http://www.daiichisankyo.com.

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO Co., Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

1 NICE Final Appraisal Determination. Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation. Issued 7 August 2015.

2 NICE Patient Decision Aid. Atrial fibrillation: medicines to help reduce your risk of stroke - what are the options? Published 18 June 2014.

3 NICE. Atrial fibrillation: the management of atrial fibrillation. Clinical guideline 180. Published 18 June 2014.

4 NICE. Thousands of strokes in people with common heart rhythm disorder are avoidable, says NICE. Press release issued 18 June 2014.

5 Giugliano R et al. Edoxaban versus warfarin in patients with atrial fibrillation. New England Journal of Medicine 2013; 369(22): 2093-2104.

6 Lip G et al. Atrial fibrillation and stroke prevention. Lancet Neurology 2007; 6(11): 981-993.


Source: Daiichi Sankyo

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