The National Institute for Health and Clinical Excellence (NICE) has issued its Final Appraisal Determination (FAD) on Sanofi-aventis' Acomplia (rimonabant). NICE also proposed guidance recommending the use of the drug in England and Wales, within its licensed indications, as an adjunct to diet and exercise for adults who are obese or overweight and who have had an inadequate response to, are intolerant of, or are contraindicated to other antiobesity agents that have previously been reviewed by NICE.
The Institute has recommended that Acomplia should be made available for the management of obese and overweight National Health Service (NHS) patients, and believes that Acomplia is a valuable addition to the limited treatment options currently available. With the growing problem of obesity requiring urgent action1 and the few treatment options available not being suitable for all patients, a further treatment alternative will be of considerable clinical benefit to healthcare professionals.
In clinical trials in obese and overweight patients, many of whom had associated risk factors such as type 2 diabetes and dyslipidemia, Acomplia was shown to help people to not only lose weight but also to improve their cardiovascular risk profile above and beyond that expected from weight loss alone. Obesity is a serious medical condition that is linked to the development of type 2 diabetes and heart disease. In the UK it is estimated that there are about 35,000 deaths a year attributed to diabetes, and cardiovascular disease is the UK's biggest killer. It accounts for 36 per cent of deaths and claims the lives of more than 208,000 people each year.
Obesity in England has more than trebled in the last two decades and the total socioeconomic cost of managing obesity/overweight and the conditions that it causes is estimated to be up to £7.4 billion per year. The recent government-sponsored Foresight report also revealed that if current trends continue by 2050 about 60 per cent of men, 50 per cent of women and 25 per cent of children in the UK will be obese, with an additional cost to society of almost £50 billion each year. NICE's decision was welcomed by the National Obesity Forum (NOF) given the huge economic burden of disease that obesity places on society.
Dr David Haslam, clinical director of the NOF said: "It is excellent news that NICE has recognised that doctors should be able to prescribe rimonabant on the NHS for the right patient. Patients who are obese or overweight are at significant risk of developing heart disease and type 2 diabetes, so it is vital that doctors have a full range of options, alongside lifestyle interventions, to help patients lose weight and cut their risk of disease. Rimonabant, in addition to diet and exercise, provides clinically meaningful weight loss and improvements in risk factor for cardiovascular disease. We now need to make sure that when final guidance is issued primary care trusts provide funding to allow doctors to be able to provide the medicine to those patients who could benefit from it."
The FAD does not constitute the Institute's formal decision; the final guidance document is expected to follow in due course.
"Sanofi-aventis has once again demonstrated its expertise and commitment to making first-in-class treatments available to patients and physicians alike. We are delighted we have been able to provide Acomplia, a truly innovative treatment, and in doing so, to contribute to reducing the burden of disease linked to obesity", said Hanspeter Spek, executive vice-president, Pharmaceutical Operations.
Acomplia (rimonabant) is approved in the European Union as an adjunct to diet and exercise for the treatment of obese patients (BMI = 30/m2) or overweight patients (BMI > 27kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia. Acomplia (rimonabant) is contraindicated in lactating patients or patients with hypersensitivity to the active substance or to any of the excipients, with ongoing major depressive illness and/or ongoing antidepressive treatment. In pivotal clinical trials lasting up to two years, rimonabant significantly reduced body weight and waist circumference, a measure of intra-abdominal fat. Rimonabant also improved glycemic control, HDL, triglycerides (fats in the blood), and insulin sensitivity. The most common adverse events associated with rimonabant were consistent across studies and included gastrointestinal (nausea, vomiting, diarrhoea), nervous system (headache, dizziness, paresthesia/ hypoesthesia/ dysesthesia) and psychiatric disorders (anxiety, insomnia, depressed mood and depression). Rimonabant has been approved for prescribing in 56 countries.