MYSIMBA▼® (naltrexone/bupropion) NICE ORAL APPEAL REJECTED

The Oral Appeal to the National Institute for Health and Care Excellence for Mysimba, the oral, anti-obesity medicine has been rejected.

Mysimba was licensed in the European Union in 2015. It is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) ≥ 30 kg/m2 (obese), or ≥ 27 kg/m2 to < 30 kg/m2 (overweight), in the presence of one or more weight-related co-morbidities (e.g. type 2 diabetes, dyslipidaemia, or controlled hypertension)1.

Commenting on the decision Ahmed Al-Derzi, Chief Executive Officer, Consilient Health said: “Consilient Health is extremely disappointed at this decision. Rejecting Mysimba, a clinically effective treatment 2-4 that can help in the fight against obesity in the UK, limits the choice of treatment options for healthcare professionals and patients”.

The UK has the highest levels of obesity in Western Europe5 with a prediction that over 50% of its population could be obese by 20506.

Professor David Haslam, a general practitioner with a special interest in obesity and cardiometabolic disease, and a physician in Obesity Medicine at the Centre for Obesity Research at Luton and Dunstable Hospital said: “Obesity increases the risk of many illnesses such as type 2 diabetes, high blood pressure, heart disease, stroke and cancer5,7. As clinicians we’re already struggling to manage this huge problem and the situation is only going to worsen. We desperately need new treatment options.”

Consilient Health, together with its partner, Orexigen Therapeutics Ireland Limited, is considering what options are available for individuals to obtain Mysimba in the UK, and a specific response to this rejection.

1. Mysimba Summary of Product Characteristics September 2017.
2. Greenway FL et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010;376 (9741):595-605. doi: 10.1016/S0140-6736(10)60888-4. Epub 2010 Jul 29.
3. Apovian CM et al. A Randomized, Phase 3 Trial of Naltrexone SR/Bupropion SR on Weight and Obesity-related Risk Factors (COR-II). Obesity (2013) 21, 935-943. doi:10.1002/oby.20309.
4. Hollander P. Effects of Naltrexone Sustained-Release/Bupropion Sustained-Release Combination Therapy on BodyWeight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes. Diabetes Care 2013 36: 4022–4029.
5. (accessed March 2017).
6. (accessed March 2017).
7. Public Health England Obesity Knowledge and Intelligence Team. Making the case for tackling obesity – why invest? https://www.noo, (accessed March 2017).

Notes to editor
Consilient Health Limited
Consilient Health is a pharmaceutical company, specialising in the commercialisation of specialty products with a focus on the therapeutic areas of women’s health and endocrinology. Consilient Health has a diverse offering, launching licenced products on behalf of major pharmaceutical companies into selected European markets, and further afield into the Middle East and North Africa region. The Company seeks to build long term collaborations with the companies it partners with, looking to differentiate itself from its competitors with ‘value-added’ innovative solutions. Consilient Health solely markets prescription medicines, choosing products where there is a clear commercial opportunity and an unmet clinical need. As an independent business, Consilient Health can upscale to suit the needs of patients, prescribers, payers and partners. The Company is headquartered in Ireland, and has commercial operations in Ireland, UK, Nordics and the Gulf Cooperation Council, as well as additional partnerships in Northern Europe.

In December 2016, Consilient Health signed an agreement with Orexigen Therapeutics Ireland Ltd to commercialise and distribute Mysimba in the UK and Ireland.

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For further information, please contact:
Louise Blakeborough, Chapter Five
T: 01483 892773
M: 07831 444789

UK/MYS/1017/0167a November 2017