Pharmaprojects R&D Pipeline News Feed
Acomplia set for launch in the UK market
31st Mar 2008
Sanofi-Aventis has received a boost with a National Institute for Health and Clinical Excellence (NICE) recommendation for Acomplia (rimonabant) to be available on the UK’s National Health Service for obesity and weight management. Acomplia is a cannabinoid CB1 antagonist which has been developed for the treatment of obesity, alcohol dependence and as a smoking cessation aid.
The drug has been launched in many markets as an antiobesity agent, but it has not had a completely smooth ride. Sanofi-Aventis withdrew its US NDA application in 2007, following an approvable letter for use in obesity and a non-approvable letter for smoking cessation, due to a rare association with suicidal thoughts or actions. When the EU’s CHMP recommended approval for obesity treatment, it included a proviso for contraindication in patients with major depression and those on antidepressants, due to the risk of psychiatric side effects.
Acomplia has also faced difficulties with a lack of reimbursement by health insurers, claiming it is a means of improving lifestyle. The UK government , however, has made fighting obesity a high priorityThis is good news for Sanofi, as so far sales of the predicted multibillion-dollar drug have been disappointing, only reaching £61.5 million in 2007, primarily down to missing out on the US market..It remains to be seen if additional clinical trial results, expected in 2009 and including extra data for Type II diabetes treatment, will change the product’s fortunes in the US.
