The oral hearing of the Appeal for the use of Mysimba▼® (naltrexone hydrochloride /bupropion hydrochloride), the oral, anti-obesity medicine, took place at the National Institute for Health and Care Excellence (NICE) headquarters in London today. The outcome is expected to be announced in November.
The Appeal was lodged following NICE’s Final Appraisal Determination issued in July, stating that Mysimba was not recommended within its marketing authorisation for managing overweight and obesity, in adults, alongside a reduced-calorie diet and
increased physical activity.
Mysimba was licensed in 2015 in the European Union, 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.
Ahmed Al-Derzi, Chief Executive Officer, Consilient Health said: “Clinicians are surprised and disappointed that Mysimba is not currently recommended by NICE,
despite its proven clinical effectiveness. Obesity is a significant and growing issue in the UK, and an additional medicine is urgently required in the management of this complex, multifactorial chronic disease. We are hoping that NICE will ultimately reverse its original decision.”
UK/MYS/1017/0164a October 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.
For more information, please visit www.consilienthealth.com
1) Mysimba Summary of Product Characteristics April 2017.
For further information, please contact:
Louise Blakeborough, Chapter Five, T: +44(0)7831 444789