While the highly anticipated diet pill Acomplia (rimonabant) may be available in Europe in a matter of weeks, Sanofi officials on May 31st gave the clearest signal yet that there is no real prospect of the prescription diet drug being on the market in the United States before 2007.

Sanofi officials -- who for the past three months have refused to provide any insights into the seriousness of the issues delaying action on approval of the diet drug by the U.S. Food and Drug Administration -- said May 30th they hoped to "be able to answer all the FDA questions by the summertime."

The disclosure to stockholders at Sanofi's annual meeting in Paris that the company still hasn't given the FDA all the data the agency is looking for makes it clear that Acomplia will not be available in the United States anytime soon.

"We still hope to get approvability in the United States between now and the end of the year," Sanofi Senior Executive Vice President Gérard Le Fur said.

Le Fur noted that a key committee of the European Medicines Agency (EMEA), the Committee for Medicinal Products for Human Use (CMPH), has recommended approval of Acomplia as an aid to weight loss, and reiterated that Sanofi is making preparations to launch Acomplia this summer in Europe.

The EMEA is widely expected to act in early July to authorize sale of Acomplia in European Union countries.

"We believe will launch as from this summer in Europe, in countries where the prices don’t have to be discussed" with the government, Le Fur said. "This isn’t the case for France, but it is the case for instance in the United Kingdom, Germany and the Scandinavian countries."

Sanofi has already identified Britain and Germany as countries where it can set its own price without negotiating with the government, and where it hopes to bring Acomplia to the market in July.

Sanofi remarks today about where Acomplia stands with the FDA, while limited, nevertheless offered more of a clue to the state of the U.S. approval process than the French pharmaceutical giant has previously provided.

If the Sanofi has been unable in three months to provide the FDA with the information it is seeking, observers believe it likely the U.S. regulatory agency has asked it to go back through the raw data from Acomplia clinical trials and provide a clearer picture of the prevalence and seriousness of rimonabant's side effects.

Acomplia is first in a new class of drugs that interferes with receptors in the brain that help regulate appetite, and trial side effects among other things included a 2.7-fold higher rate of psychiatric disorders.

Most observers also believe the FDA will not act until the high-profile diet pill is thoroughly vetted by an advisory panel of independent outside experts.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee, which would be the panel to consider Acomplia, has cancelled all of its tentatively scheduled meetings for the balance of the year, though a meeting to consider Acomplia could yet be convened on relatively short notice.