Sanofi-Aventis said it had at last finished its response to concerns the Food and Drug Administration has raised about diet drug rimonabant (Acomplia / Zimulti), but decline to reiterate its earlier forecasts that the diet pill would be approved in the U.S. before the end of the year.

"We will not speculate at all what the FDA now has to do or will do and within which timeline," Hanspeter Spek, head of pharmaceutical operations, said during a conference call.

The French drugmaker again provided no clue as to the concerns the FDA raised when it issued a so-called "approvable" letter in February. But the fact that it took Sanofi more than eight months to submit a "complete response" suggests major issues remained -- and perhaps still remain -- to be resolved.

The only hint Spek was willing to provide was that Sanofi, as part of its continuing bid to get Acomplia approved in the U.S., has not submitted new data to the FDA either from clinical trials or from experience to date with patients in Europe where the diet pill already is on sale in seven countries.

"We are not in the process of negotiating with the American authorities the approval of the product," Spek said. "We have received an 'approvable' letter and in this case the 'approvable' letter contained questions. The 'approvable' letter did not ask for new clinical trials. It is easy for me to say we have not submitted new data."

The big question now that Sanofi finally filed its complete reponse on Oct. 26th is whether the FDA will in the next two weeks assign a Class 1 or Class 2 status to review of the filing.

A Class 1 resubmission would be one in which the FDA seeks to review and act within two months, while a Class 2 resubmission would indicate a six-month timeline for action. Any resubmission that requires consideration by an FDA advisory panel automatically is assigned Class 2 status.

Many analysts now believe a Class 2 review is far more likely, which would give an FDA advisory panel time to weigh issues involved with the Acomplia -- and in particular its side effects -- sometime in the early part of 2007.

In keeping with Sanofi's longtime refusal to provide any information about the holdup on Acomplia, however, Spek indicated Sanofi has no intention of sharing the news when the FDA notifies it whether it will conduct a Class 1 or Class 2 review.

"From what i see today, we will not make a public statement until we have a reaction from the FDA," Spek said.

The continuation of Sanofi's stonewalling on questions about Acomplia clearly frustrated analysts, who pressed harder than in sessions earlier this year for clarification on what is really happening at the FDA.

"In our view," said a Societe General analyst, " there are further doubts on management's credibility."

source from: http://www.acompliareport.com/News