Sanofi Aventis told a UK newspaper this week that its new obesity pill Acomplia (rimonabant) is close to getting approval from the European Commission.
“We are 99.9 % sure of approval,” a Sanofi Aventis spokesman told The Independent.
The Committee for Medicinal Products for Human Use, an advisory group to the European medical regulator, the European Agency for the Evaluation of Medicinal Products, recommended on April 28 that Acomplia be approved for obese patients and overweight people with type 2 diabetes or dyslipidemia.
US approval for Acomplia is seen as crucial. The FDA issued an approvable letter for Acomplia in February, asking for more time and information before the agency renders a final decision.
Sanofi’s head of research and development, Gerard Le Fur, said at the company’s general meeting in Paris last week that he expects to get US approval by the end of 2006.
Some observers believe Acomplia has the potential to become the world’s best-selling prescription drug, with analysts’ sales estimates at $4 billion annually by 2010.