NICE recommends weight management treatment, Saxenda (liraglutide 3mg), for people with a BMI of ≥35 kg/m2 , prediabetes and a high risk of cardiovascular disease

Ref: Novo Nordisk

• Saxenda® (liraglutide 3 mg) will be the first once-daily glucagon-like peptide-1 (GLP-1) treatment for obesity available on the NHS in England1 –and the first pharmacotherapy to be endorsed by NICE for weight management in over a decade2

• 13 million adults in England haveobesity,3a significant risk factor for the development of chronic diseases such as type 2 diabetes3 , and poorer outcomes fromCOVID-194

• NHS England treatment will be available to adult patients with a BMI ≥35 kg/m2who have prediabetes and a high riskof cardiovascular disease1

Gatwick, UK, 00:01, 30 October 2020 - Novo Nordisk announced today that the National Institute for Health and Care Excellence (NICE) has recommended Saxenda® (liraglutide 3 mg) for use on the NHS in England, for weight management.1 It has been recommended alongside a reduced calorie diet and increased physical activity, for adults with a BMI ≥35 kg/m2*who have non-diabetic hyperglycaemia (pre-diabetes) † and a high risk of cardiovascular disease, based on risk factors like high blood pressure and cholesterol.1 Theinjectable GLP-1treatment will be utilised by multi-disciplinary teams within specialist tier 3 weight management services in the NHS in England, alongside existing interventions which include lifestyle modifications. 1

The safety and efficacy of Saxenda® (liraglutide 3 mg) for weight management in conjunction with reduced calorie intake and increased physical activity was evaluated in the SCALE® (Satiety and Clinical Adiposity - Liraglutide Evidence) phase 3a clinical trial programme– which included over 5,000 participants. Across all SCALE® clinical trials, people with overweight or obesity treated with Saxenda® (liraglutide 3 mg) achieved superior weight loss compared with placebo, and a greater proportion of people achieved ≥5% and >10% weight loss. NICE’s recommendation is largely based on the findings of the SCALE® obesity and prediabetes trial.5

At the end of the SCALE® obesity and prediabetes trial (at 160 weeks), people treated with Saxenda® (liraglutide 3 mg) were less likely to have been diagnosed with type 2 diabetes compared with placebo (3% vs 11%, respectively).5

The patient population selected for this NHS treatment are most likely to benefit from Saxenda® (liraglutide 3 mg), and are an identifiable group at high risk of experiencing the adverse consequences of obesity.

Dr Abd Tahrani, Senior Lecturer in Metabolic Endocrinology and Obesity Medicine and NIHR Clinician Scientist,University of Birminghamsaid: “The issues of obesity and type 2 diabetes remainshigh on the political and media agenda because of COVID-19, but it is critical that these discussions are met with evidence-based solutions. Obesity has multiple causes and requires long-term management, and it is important that the clinical community and patients have access to a range of effective treatment options available on the NHS to support people living with obesity. This is the first weight loss pharmacotherapy to be recommended by NICE for the prevention of type 2 diabetes in certain groups of patients, so this is a critical milestone that will help the NHS to meet the needs of patients living with obesity and pre-diabetes.”

Professor Carel Le Roux, Professor of Metabolic Medicine,Imperial College London, added: “It has never been more important for the healthcare community to prioritise supporting people living with obesity, given its strong links to poorer outcomes with COVID-19, as well as a range of other conditions including diabetes and cardiovascular disease. Saxenda® (liraglutide 3 mg) has a well-established record in not only promoting weight loss but enhancing cardiometabolic benefits for patients. The addition of this treatment on the NHS is fantastic news, as it offers the potential to help patients whilst alleviating pressure on the NHS duringthis challenging time.”

Pinder Sahota, Corporate Vice President and General Manager, Novo Nordisk UK, said: “We are delighted that NICE has recommended Saxenda® (liraglutide 3 mg) for the treatment of obesity on the NHS. This is testament to the value that this treatment offers, particularly during these challenging times, when policymakers and clinicians are highly focused on finding effective ways to address the prevalence of obesity across the UK.We remain committed to our purpose in driving forward change forpeople living with complex conditions like obesity, and look forward to continuing to work alongside our NHS Englandpartners.”

Across the SCALE® clinical trials, the most common adverse events for Saxenda® (liraglutide 3 mg) were transient gastrointestinal adverse events including nausea, vomiting, diarrhoea and constipation.5