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Acomplia launched in UK

Published on 29/06/06 at 04:52pm

Acomplia, the long-awaited weight-loss drug from Sanofi-Aventis has been launched in the UK, and promises to help patients shed pounds and also combat type II diabetes and cardiovascular disease.

The first-in-class drug could be a major breakthrough in treating the obesity epidemic and could be a useful tool for preventing and treating diseases such as type II diabetes and heart disease.

Sections of the media have hailed the drug as the latest 'wonder pill', but Sanofi-Aventis must first convince doctors the drug is not merely an expensive gimmick and that its side-effects are within acceptable limits.

The weight of evidence

The company has made a good start to winning over doctors, presenting strong evidence to suggest Acomplia helps patients to lose weight and then keep it off, and also that it lowers blood-sugar and cholesterol levels.

Crucially, trials suggest Acomplia (rimonabant) works above and beyond simply helping patients lose weight, as blood-sugar and cholesterol levels are lowered to a greater extent than would normally be seen though weight-loss alone.

The drug's European licence specifies that it should be used as an adjunct to diet for those overweight and obese patients with associated risk factors such as type II diabetes or dyslipidaemia.

Analysts believe this direct effect on diabetes and high cholesterol will help Acomplia establish itself as a 'serious' medicine for killer diseases, and distance it from the reputation of older weight-loss drugs, which often had undesirable side-effects or limited efficacy.

Acomplia is the first drug that works by selectively blocking CB1 receptors found in the brain, in peripheral organs and fatty 'adipose' tissue. Clinical trials have shown that by blocking these receptors, the drug helps to suppress appetite and, therefore, aids weight loss when taken in conjunction with a restrictive diet and an exercise programme.

Over a year, patients lost on average 6.5kg (approximately one stone) in weight, and patients remaining on the pill kept the weight off for up to two years. This level of weight loss would be expected to naturally improve cholesterol and blood-sugar levels, but trials showed 50% of the improvements in these two indicators was independent of weight loss.

This is thought to be achieved by blocking the release from body fat of hormones which raise blood-sugars and triglycerides, the latter being fats associated with heart disease.

Side effects

Acomplia is far from being entirely free of side-effects, however, and this could ultimately limit the uptake of the drug in the UK and elsewhere.

Phase III trials showed some patients suffered depression while on the drug, and doctors have been instructed not to give Acomplia to anyone with uncontrolled, serious psychiatric conditions such as depression.

Consequently, Acomplia is not recommended for anyone taking anti-depressants, a cautionary measure which could limit the drug's use significantly.

Upper respiratory tract infections and nausea were also reported as very common side-effects in trials, with memory loss and dizziness among a number of other less common adverse effects.

Nevertheless, analysts believe the drug could hit peak annual sales of $1.5 billion, and the company says it is still pursuing a second licence for smoking cessation which could boost sales further.

Maiden launch in UK

The UK is Acomplia's very first market, and a number of the country's most eminent doctors were assembled to announce its arrival to the media on 28 June.

Anthony Barnett, clinical director of diabetes and endocrinology at Birmingham Heartlands Hospital was among those proclaiming the benefits of the new drug  and warning of the serious health risks of obesity.

Barnett says forecasts suggest the UK could overtake the US in the obesity stakes within the next 20 years to become the fattest nation in the world.

"Obesity is a massive problem and takes up to 10% of the NHS budget," he said. "There are now around 200 million people in the world who are obese and the figure is expected to rise to 370 million by the year 2025."

The drug is aimed at helping abdominally obese patients to lose weight. Sanofi-Aventis is urging GPs to identify these patients by simply measuring their waist circumference. Women are classified as obese with a waist measurement of 35 inches or more; men with a measurement of 40 inches or more.

Research suggests this is a far superior measure of whether a person is overweight and at risk from type II diabetes compared with the traditional use of the BMI measurement. This is because waist circumference is a measure of abdominal obesity and indicates the presence of excess visceral fat - which is thought to be directly linked to the onset of diabetes and high levels of triglycerides and cholesterol.

In clinical trials involving more than 6,800 patients, Acomplia (rimonabant) 20mg demonstrated significant reductions in waist circumference over a two-year period. Doctors speaking at the press launch pointed out that around a third of the population in the UK currently under the age of 65 is expected to die prematurely of cardiovascular disease, and this is exacerbated by high risk factors, such as diabetes and obesity. In fact, obesity is such a serious health problem, it costs the NHS four billion pounds a year. Furthermore, the number of patients in the UK with type II diabetes is expected to rise to three million by 2010.

Promotion of Acomplia is be focused at primary care services, where GPs are seeking alternative treatments to control patients with chronic obesity, many of whom also have diabetes and/or high cholesterol levels.

At around 54 pounds a pack, for 28 days' supply at a dose of one pill a day, Acomplia is more expensive than Roche's Xenical, the biggest selling weight control prescription medicine currently on the market.

Xenical is priced at just under 40 pounds for a pack of 40 pills (one to be taken up to three times a day), and earned 27 million pounds through GP prescribing in 2005. Despite being effective in helping patients lose weight, Xenical has a long list of serious and unpleasant side-effects which means many patients struggle to maintain treatment.

Meanwhile ,Sanofi-Aventis says it will shortly gain US approval for Acomplia. Dr Whitehead said: "We received an 'approvable letter' from the FDA in April and there is certainly no requirement for further trials from the FDA for the drug."

The company says it remains unclear whether or not it will continue to pursue a licence for a second indication for Acomplia in smoking cessation. US and European regulators both rejected the company's applications for this indication earlier this year.



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