Heartwire 2007. © 2007 Medscape
June 13, 2007 (Silver Spring, MD) - In a blow to the drug maker, as well as millions of overweight and obese Americans hoping for a new weight-loss medication, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously to send Sanofi-Aventis back to gather more detailed safety information about rimonabant over the long term, in larger patient numbers.
After a day of discussion and presentations, all 14 members of the advisory committee agreed that rimonabant did not demonstrate a risk/benefit profile to enable it to be approved for the indication the sponsor was seeking: weight management in individuals with a body-mass index of >30 kg/m2 or in individuals with a BMI of >27 kg/m2 when accompanied by at least one comorbid condition.
The committee's concerns centered on what many concluded was a "clear" signal of increased risk of neurological side effects—seizures, depression, anxiety, aggressiveness, and suicidal thoughts among patients randomized to rimonabant. Many were also concerned about the low number of patients—441 in total—who had actually been taking the 20-mg dose for out to two years. Several panel members stated that even current, ongoing studies of rimonabant, including the CRESCENDO study, are not appropriately designed to clarify the types of adverse events occurring in people taking the drug.
A more detailed report on the rimonabant hearing will be posted by heartwire on Thursday.
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