U.S. panel rejects Sanofi obesity drug
SILVER SPRING, Maryland (Reuters) - U.S. regulators should reject a proposed weight-loss pill called Zimulti because of concerns it may increase suicidal thinking and depression, an advisory panel unanimously said on Wednesday.
French drugmaker Sanofi-Aventis SA (SASY.PA)(SNY.N) sells the medicine in 18 countries under the name Acomplia. Advisers to the Food and Drug Administration said there were too many questions about potential side effects to support U.S. approval.
"I think this is a drug that needs further understanding with respect to what it does to people's psyche," said Dr. Sid Gilman, a panel member and a University of Michigan neurologist.
The FDA usually follows panel recommendations. A final decision is expected by July 26.
Sanofi said in a statement it would work with the FDA to address the committee's decision.
In the past, the company has forecast peak annual sales of $3 billion or more for the drug, but the negative ruling makes it unlikely the company will be able to sell it in the world's largest pharmaceutical market.
Known generically as rimonabant, Zimulti is a new type of drug that helps people shed pounds by blocking food craving signals in the brain. Sanofi developed it to target receptors that trigger intense hunger after marijuana use.
In company studies, Zimulti plus a reduced-calorie diet helped patients lose about 5 percent more than diet alone over one year. Patients who took the drug lost an average of 14.2 pounds, while others who got a placebo dropped about 3.5 pounds.
Zimulti also reduced waist size and improved levels of "good" cholesterol, blood sugar and blood fats called triglycerides, Sanofi said.
"I believe rimonabant can offer a positive balance between likely benefits and potential risks," said Dr. Louis Aronne, a Sanofi consultant and professor of medicine at Weill Cornell Medical College.
But FDA reviewers said data showed Zimulti patients were twice as likely to have suicidal thoughts or mental problems such as depression and anxiety. Twenty-six percent of patients reported a psychiatric symptom, compared with 14 percent of placebo patients.
"The potential market for this drug and our continued uncertainty about its risks, both known and unknown, lead to our concern" about use in the general population, said FDA medical officer Amy Egan.
Sanofi said the risks were manageable, mainly by warning against use by people with past or current depression or on antidepressant treatment.
Company officials also said suicidal thinking and behavior was rare. In studies, 0.63 percent of Zimulti patients reported thoughts of suicide, compared with 0.38 percent of placebo patients.
Sanofi said there was no evidence Zimulti caused suicidal thoughts or actions, but the FDA's Egan disagreed. Continued...
