News »July 2007

Sanofi still hopeful of making way for its diet drug acomplia to U.S. Market

July 31, 2007

Sanofi-Aventis still anticipates that its diet drug acomplia will exceed the FDA's approval process to be marketed in the United States, avowed Heinz-Werner Meier, the company's head of German operations.

"That matter has not yet been dashed off. The FDA may contradict use of Acomplia for patients with depressive illnesses, which would be identical to the European Medicine Agency's stipulation for allowing the anti-obesity to remain on sale in European Union countries", Sanofi's head of German operations Heinz-Werner Meier added.

One week ago, the European Medicine Agency asked the French drug maker to add a stronger safety warning concerning the unsuitability of acomplia for people with depression. .

After receiving severe criticism from the FDA's expert advisory panel over acomplia's connection with depressive side effects, Sanofi last month gave up the hope of seeing its diet drug marketed in the United States and pulled its NDA in the United States.

"We did not get success in America, so there will be some financial ramifications too," Meier further affirmed.

Though some analysts had prior projected that Acomplia might be a $5 billion remedy, devoid of the U.S. market, few anticipate the diet pill to receive the worldwide sales of above $500 million.