Acomplia poised for approval as NHS focuses on fighting fat
pharmafile | May 30, 2006 | News story | Sales and Marketing |
Acomplia, the first-of-a-kind weight-loss drug, is set to gain approval across Europe within the coming weeks, offering a new hope to patients struggling to shed pounds and improve their health.
The drug looks likely to hit the market at just the right time in the UK, where the NHS has been set new targets to tackle the growing obesity epidemic.
Sanofi-Aventis' product gained a recommendation from the EMEA's expert committee in April, and is expected to gain full approval shortly and then reach European patients by the end of 2006.
The company had sought to market the drug for two uses - as a weight-loss drug and as a smoking cessation treatment – but the latter indication was refused in Europe, as had happened some weeks earlier in the US.
Nevertheless, analysts believe the strong evidence of the drug's effectiveness in helping patients lose weight will help it become a major seller, with peak sales forecast in excess of $1 billion.
Europe continues to see ever-increasing numbers of people becoming overweight or obese, with more than half the adult population overweight in many countries, and as many as one in three people being classified as clinically obese.
Figures from the World Health Organisation show England in the top five of Europe's most obese populations for both men and women. Only Greece has more overweight or obese women than England. Germany has the largest number of overweight men in Europe, followed by Greece, Finland, Ireland and England.
The NHS in England has been instructed to focus more on helping the most obese and overweight patients tackle their condition, with doctors and nurses given advice on how to raise the subject sensitively and help patients stick to a weight loss plan.
The government has set a target to halt the year-on-year rise in obesity among children under 11 by 2010, as part of a broader strategy to tackle obesity in the whole population.
Acomplia's arrival on the market is therefore very timely, with primary care staff now focusing on the problem as never before, although the drug will not be available to prescribe to children.
Acomplia (rimonabant) can only be used as an adjunct to diet and exercise in obese patients (BMI greater than or equal to 30kg/m2) or overweight patients with risk factors such as type II diabetes or high cholesterol.
As with existing weight-loss drugs available on prescription, these restrictions are there to ensure the drugs are not abused or used without other back-up action to lose weight.
Prof Luc Van Gaal of the Antwerp University Hospital, Belgium and principal investigator of the RIO Europe trial indicated that by assisting patients to lose weight, it could help prevent or delay the onset of serious health conditions, such as heart attacks and diabetes.
He said: "Obesity levels in the European Union have risen significantly in the past decade in the adult population, and this represents a serious public health concern.
"Specifically, those with abdominal obesity are at the greatest risk of developing type II diabetes and heart disease, due to the link between abdominal obesity and other risk factors.
"Acomplia is an innovative, first-in-class treatment which will offer physicians a new approach to managing multiple cardiometabolic risk factors in patients with abdominal obesity who have other conditions such as type II diabetes, or unhealthy lipids."
He stressed that Acomplia should be used responsibly: "We should only use this drug in such patients where there is a real medical need, and not in people who may seek to use it for cosmetic reasons."
Roche's Xenical and Abbott's Reductil are two prescription treatments already available to help patients lose weight, but are not used extensively by doctors in England.
Xenical, the biggest seller of the two drugs, saw its sales in primary care rise by 22% in 2005, earning Roche 27 million pounds.
Sanofi-Aventis is hoping Acomplia will outperform these drugs, and it will use data from its trial to convince doctors of the proven cardiovascular benefits of its product.
More than 6,600 patients worldwide have been studied for up to two years in the RIO trial, which showed 20mg of Acomplia every day helped to reduce weight and waist circumference, as well as blood glucose, cholesterol and triglycerides levels in patients.
