Diet drug Acomplia / Zimulti (rimonabant) has now been taken by more than 200,000 obese and overweight patients in Europe and a handful of other countries, but Sanofi-Aventis offered no encouragement on Aug. 1 to those hoping to see it approved for early sale in the United States.

Executive Vice President Hanspeter Spek, talking to financial analysts, said that in the wake of Sanofi's decision in June to withdraw its application to sell Zimulti in the U.S., "we have since received confirmation from the FDA that the FDA is ready to talk to us once again."

"The FDA has formally acknowledged that we have a strong file and has given us notice that they are absolutely ready to see us again with this file as soon as it can be completed by additional data confirming the benefit-risk profile of Zimulti in the United States," Spek said.

During his presentation and in response to questions, Spek repeatedly said a resumption of efforts to get the FDA to approve Zimulti -- which was originally submitted to the agency in 2005 -- would be "data driven."

A major concern of an FDA advisory panel, which in June unanimously recommended against permitting sale of Zimulti in the United States, was that Sanofi had presented insufficient data regarding such side-effects as depression and suicidality to warrant approval of the drug for long-term use.

"Data driven first of all means of course whatever may come out of the regular reporting of side effects (on use of Acomplia by patients in Europe and elsewhere) of course we will share with the FDA," Spek said.

But he appeared to hold out little hope that this data on the product's use in Euroope -- where the European Medicines Agency has decided to leave Acomplia on the market but with a strong warning label -- would change the situation at the FDA.

"I think more likely are two steps," Spek said.:

"The expected results of the ongoing studies in diabetes which will become available in 2008 and beginning of 2009, and then second the very, very important results coming out of the so-called CRESCENDO study which is basically confirmation of the long-term benefit (of rimonabant) which is being expected for 2010.

"As soon as those data will become available and suppose as they are positive, we will redeposit then the file also in the United States of America," Spek added.