Sanofi-Aventis, developer of the novel weight-loss drug Acomplia (rimonabant), continues to hint that it expects the U.S. FDA to approve the drug in the next few weeks -- enabling doctors to begin prescribing it before the end of June.
The Philadelphia Inquirer reported on Feb. 4th that If Acomplia gets marketing approval from the FDA later this month, Sanofi "has said it could begin selling the pill by June 30."
Other reporters who were hand-picked to participate in a conference call on Feb. 2nd with Dr. Douglas Green, Sanofi's vice president for regulatory affairs, said they came away with the impression that he expected approval in the next couple of months.
"We're down to the wire with the FDA," Sanofi senior vice president Porter McMillian Jr., head of U.S. operations based in Malvern, PA, told the Inquirer.
Perhaps the biggest unknown at the moment is what Sanofi has asked the FDA to approve in terms of medical indications for the drug's label.
While Sanofi two years ago was talking about Acomplia as a breakthrough weight-loss drug, clinical trial results subsequently showed that it also improved good cholesterol, lowered triglycerides, reduced other cardiac risk factors, and helped obese diabetics lower their all-important HbA1c level -- a measure of blood sugar control.
Participants on this week's Sanofi conference call said the focus was all on metabolic syndrome -- with hardly a mention of weight loss!
This new focus obviously recognizes the reality that if Acomplia is approved for weight-loss alone, that indication may not be enough to get health-insurance plans to agree to pay for the drug. This has been a major problem for other prescription weight-loss drugs like Xenical and Meridia.
"Obesity medications get no respect," Thomas Wadden, director of the University of Pennsylvania's Weight and Eating Disorders Program, told the Inquirer. "There would be a lot more people on the medications if they were reimbursed -- $100 a month out-of-pocket forces some people to choose between their car payment or their weight-loss drug.
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