Sanofi’s new anti-obesity pill is having problems gaining approval in the U.S. and is facing opposition in Germany and France, which have put limits on paying for the drug over there.

This, according to an article in today’s Wall Street Journal (see “‘Miracle’ Obesity Pill Looks Less Miraculous“; subscription required).

It is rumored that the FDA is concerned about the drug’s adverse psychiatric effects, including increased aggression. “Frederick West, a 64-year-old with diabetes in Hertfordshire, England, began taking the drug. He lost about 15 pounds in the first few months, but after about four months he started experiencing mood swings including periods of aggression. Mr. West works as a gamekeeper on a large English estate, where he is sometimes required to carry a gun.”

But not only do gun-totting gamekeepers need to be carved out of the potential user pool — so do women who wish to fit into their bikinis, according to Hanspeter Spek, Sanofi’s head of pharmaceutical operations: “We have a strong, even vital interest to show that our patients are not those that take the product in order to fit into their bikini.”

Thank you, Mr. Spek for giving me an opportunity to put guns and bikinis together into the same blog post title!

On a more serious note…

Sanofi has learned a lesson about how to position a product for the market. Acomplia was supposed to conquer fat, smoking, high cholesterol, and diabetes. When you try to be everything, you just leave the door wide open for critcism on all fronts, instead of just one front. Focus, focus, focus…

The FDA already was quick to reject the application for smoking cessation and is asking for more information about Acomplia’s anti-obesity prowess.

The problem is the drug’s adverse psychiatric effects: “Patients on the 20-milligram dose had a 6.2% rate of psychiatric disorders such as depression, compared with 2.3% of those taking a placebo,” reports the WSJ.

The FDA is rightly concerned about such side effects of drugs that must be taken over long periods of time.

Sanofi is now trying to reposition Acomplia as a treatment for diabetes (or metabolic syndrome).

“Gérard Le Fur, who was Sanofi’s head of research and development for more than a decade before becoming chief executive in January, now says, ‘If we were to start again, we would say it’s an antidiabetic agent’ that induces weight loss.”

Woulda Coulda Shoulda.