Sanofi-Aventis’ new obesity drug Acomplia underwent its first global launch yesterday in the UK, bringing new hope to the burgeoning number of patients battling the condition.
The drug - a first-in-class offering which works by selectively blocking CB1 receptors in the brain and other organs that play an important role in glucose and fat metabolism - was approved in Europe last week for use alongside diet and exercise in treating overweight or obese patients with signs of dyslipidaemia and other associated risk factors.
Sanofi-Aventis is targeting patients with so-called cardiometabolic risk factors - including high LDL cholesterol and hypertension - that predispose an obese patient to develop type 2 diabetes or cardiovascular problems. Of growing importance, it says, is the role of abdominal obesity - so-called the 'apple' versus 'pear' shape - which has a particular association with the emergence of insulin resistance, low levels of the 'good' HDL-cholesterol, high triglyceride levels and raised inflammatory mediators such as C-reactive protein.
Acomplia’s (rimonabant) efficacy was demonstrated in an extensive 6,600-patient clinical trial program, dubbed RIO, which found that it dramatically cut overall weight and, importantly, waist circumference. It also had a beneficial effect on HbA1c - a measure of blood glucose - triglycerides and HDL-c: in fact, the label granted by the European Commission states that an estimated 50% of the observed improvements in HbA1c, triglycerides and HDL-c were beyond that expected from weight loss alone.
Obesity is a huge problem across the world that is reaching epidemic portions. In the UK, the number has quadrupled in the last 25 years to nearly 10 million and, as obesity boosts the chance of developing diabetes by a factor of 80, the problem is multi-tiered.
The economic costs related to the condition are snowballing too; obesity costs the UK around £4 billion a year, and diabetes accounts for around 10% of the country’s total healthcare budget, so Acomplia’s price tag of £55 for a month’s supply actually seems quite reasonable.
Advocating the use of the drug to help fight the growing problem, which could see the UK overtake the USA in terms of the percentage of obese in its population in the next 20 years, David Haslam, a GP and Clinical Director of the National Obesity Forum, warned a press conference in London yesterday: “We have a limited window of opportunity to do something about it. Prevention is not enough.”
Acomplia is widely tipped to become a future blockbuster and represents a key player in Sanofi's growth strategy. In fact, a recent report from Decision Resources revealed that the metabolic syndrome market looks set to nearly double over the next few years, leaping from $9.5 billion in 2004 to just shy of $18 billion in 2014 in response to a sharp rise in demand for such therapies.
Analysts are predicting that the market will be driven by Acomplia, and although Sanofi-Aventis’ head Nigel Brooksby would not be drawn to a specific sales figure, he told PharamTimes Magazine “we are definitely talking billions. Acomplia will be a blockbuster.”
But it could see a rather slow start in the UK depending on the number of primary care trusts that decide not to prescribe it until the National Institute for Health and Clinical Excellence stamps the seal of approval for its use on the National Health Service. And, going on recent NICE decisions that have raised a few eyebrows, whether it will rule in favour of Acomplia is by no means a certainty.
Nigel, however, seemed unconcerned. “NICE do a very good and a very thorough job. We have engaged the appraisals procedure with them and out application is backed by very strong data.”
The company said that it will begin rolling out Acomplia in other European Union countries very soon, and also expects a licence in the US before year-end, having responded to the issues raised by US regulators in an approvable letter sent earlier this year.