Acomplia filed in Europe and US
pharmafile | June 24, 2005 | News story | Sales and Marketing |Â Â Â
Sanofi-Aventis has submitted its new obesity treatment Acomplia to the European Union and US regulators.
Even before its filing Acomplia (rimonabant) has attracted a great deal of media interest, with its ability to help patients lose weight safely, while also demonstrating the power to help smokers kick their habit.
Acomplia works by blocking signals from the CB1 receptor in the brain, part of the endocannabinoid system, which regulates hunger and is also thought to play a role in tobacco dependence.
Sanofi-Aventis is keen to distance Acomplia from the poor reputation and safety record of slimming pills and has found strong evidence the drug could help prevent cardiovascular disease beyond simply helping patients to lose weight.
Trials have shown the drug has a beneficial affect on key metabolic parameters independent from the weight loss observed. They show levels of HDL-C ('good cholesterol') are raised by the drug whereas levels of triglycerides, blood glucose and C-reactive proteins (CRP), a key marker for cardiovascular inflammation, are all lowered.
Announcing the filings, the company said: "Despite therapeutic advances in recent decades, cardiovascular disease remains the leading cause of mortality worldwide. Current treatments generally target risk factors individually, rather than providing a comprehensive management approach to such cardiovascular risks as dyslipidaemia, abdominal obesity and insulin resistance, which comprise the metabolic syndrome."
Sanofi-Aventis estimates that as many as 50 million Americans have metabolic syndrome and a trial studying Acomplia in prevention of cardiovascular disease has already begun.
The drug could gain approval on both sides of the Atlantic by the end of 2005, and analysts predict peak annual sales in excess of $1 billion.
Related articles:
Newly created Sanofi-Aventis buoyed by Acomplia
Thursday , September 02, 2004
