September 15, 2010 — The U.S. Food and Drug Administration (FDA) held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia® in the United States). In response to the Advisory Committee's mixed vote, Abbott issued the following statement:"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine. Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."
"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun. "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."
The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia. Abbott intends to consult with the FDA on sibutramine moving forward.
Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment. More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information... Abbott's Press Release -
