Sanofi-Aventis won approval in Mexico for its obesity drug Acomplia, the first time the new product was been registered in a North American market.
Acomplia (rimonabant) is also cleared for marketing and available in a number of countries in Europe, but is still awaiting approval in the important US market. Sanofi said it expects to launch the product in Mexico at the beginning of 2007.
In Mexico, the Ministry of Health gave a green light for the drug to be used as an adjunct to diet and exercise for obese patients or overweight people at risk of diabetes and heart disease.
Crucially, the Mexican authorities have allowed a label claim for Acomplia saying that it can be used in conjunction with diabetes drugs – metformin and sulfonylureas – to improve blood sugar levels in diabetics. This is something that has not featured in labelling for the product in Europe.
It has been suggested that positioning the product as a diabetes treatment could help encourage its take-up and avoid the possibility of it being dismissed as a ‘lifestyle’ drug. Results from the SERENADE trial looking at its ability to improve blood sugar control in type 2 diabetics, are due to be unveiled next month.
Sanofi has said it expects Acomplia to become a blockbuster product with peak revenues of $3 billion or more, and it made the first contribution in the third quarter, adding 11 million euros in sales to the company's coffers.
However, its future remains somewhat uncertain as government advisors in Germany have said the country's healthcare system should not reimburse treatment with the drug, while its development in the USA has been held back by a request for more information by the Food and Drug Administration.