Obese patients in the UK are a step closer to getting easier access to Sanofi-Aventis’ weight loss drug Acomplia, after the country’s spending watchdog proposed recommending its use on the National Health Service.

Acomplia (rimonabant) was first approved in Europe in 2006 as an adjunct to diet and exercise for the treatment of obese or overweight patients with associated risk factors such as type 2 diabetes or dyslipidaemia, and was once hailed as a potential blockbuster for the firm.

But since its approval Acomplia’s progress has been hit with a number of setbacks: its marketing application was pulled in the US after it looked unlikely that approval would be granted because of potential psychiatric side effects; European regulators added stronger warnings against using the drug in patients with major depression or those taking antidepressants; and the German Ministry of Health refused to fund its use on its health insurance programme because it classed Acomplia a ‘lifestyle’ drug.

So news that the UK’s National Institute for Health and Clinical Excellence has issued its Final Appraisal Determination endorsing the use of Acomplia on the NHS in England and Wales in patients who have not responded or cannot take other antiobesity agents will be very welcome news indeed.

In fact, Sanofi says it is “delighted” with the recommendation, particularly as the obesity crisis is snowballing and there are limited treatment options currently available. “With the growing problem of obesity requiring urgent action 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”, the group claimed.

Obesity is a serious medical condition linked to the development of type diabetes and heart disease, which respectively kill 35,000 and 208,000 people in the UK every year alone. According to Sanofi, Acomplia has shown its ability in clinical trials to not only help patients shed pounds but also “improve their cardiovascular risk profile above and beyond that expected from weight loss alone”, and so offers an important benefit over rival therapies.

Economic drain
But aside from the detrimental health effects of obesity, the condition, the prevalence of which has more than trebled in the last 20 years in the country, has a huge economic impact too, with the cost of its management estimated to be a breathtaking £7.4 billion per year.

And it seems that things are only going to get worse – the recent government-sponsored Foresight report has forecast that if things continue as they are, around 50% of women, 60% of men and a quarter of all children in the UK will be obese by 2050, with an additional price tag of £50 a year to the economy, highlighting the urgent need to address the problem now.

Unsurprisingly, NICE’s decision to recommend the use of Acomplia has been welcomed by the National Obesity Forum: “It is excellent news that NICE has recognised that doctors should be able to prescribe rimonabant on the NHS for the right patient,” remarked its clinical director David Haslam.

“Rimonabant, in addition to diet and exercise, provides clinically meaningful weight loss and improvements in risk factor for cardiovascular disease [and] 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,” he stressed.