Sanofi-Aventis still believes there is a good chance diet drug Acomplia (rimonabant) ultimately will be approved by the U.S. Food and Drug Administration for marketing in the United States, according to the company's head of German operations Heinz-Werner Meier.
"That subject has not yet been written off," Sanofi's head of German operations Heinz-Werner Meier told the Munich newspaper Sueddeutsche Zeitung on July 22nd.
Meier said the FDA may demand that Acomplia be contraindicated for patients with depressive illnesses, which is very similar to the stiffer warnings the European Medicine Agency proposed a week ago in allowing the diet drug to remain on the market in European Union countries.
Sanofi last month temporarily gave up on efforts to market Acomplia in the United States, pulling its application after an FDA expert advisory panel unanimously recommended against allowing the diet drug to be sold in the U.S. because of concerns over depressive side effects including suicidal thoughts.
"We have lost time in America, so there will be economic consequences," Meier told Sueddeutsche Zeitung. While some analysts had earlier estimated that Acomplia could be a $5 billion drug, without the U.S. market, few expect the diet pill to have total worldwide sales of more than $500 million.