FDA Issues Approvable Letter on Acomplia

The FDA issued an approvable letter on weight management today for Acomplia (rimonabant), spelling out the steps Sanofi-aventis needs to take to win final approval for its much-heralded diet drug. They do not approve it for smoking-cessation

Neither the company nor the FDA revealed the specifics of the letter. In a press release issued in Paris, the company said "Sanofi-aventis will continue to work in close collaboration with the FDA."

The FDA sent Sanofi-Aventis an "approvable" letter for Acomplia to be used for weight management. An approvable letter means the company must meet certain conditions before a product can be sold. The FDA would not comment on the reasons for its decision, or specify the conditions that the company will have to meet.

Sanofi-aventis also said the FDA issued a non-approvable letter for the indication of smoking cessation for Acomplia.
Just this week investigators for the RIO-North America trial reported in the Journal of the American Medical Association that a year of treatment with 20 mg of Acomplia was associated with an average weight loss of almost 14 pounds and a waist reduction of 2.4 inches, versus just under four pounds and less than an inch in the placebo group (P<0.001 for both).
Moreover, patients treated with 20 mg of Acomplia and calorie reduction for a year increased HDL cholesterol by 12.6% versus a 5.4% increase in the placebo arm (P<0.001) and decreased triglycerides by 5.3% versus a 7.9% increase for patients taking placebo (P<0.001).

In year two, 40% of patients maintained on 20 mg achieved "a weight loss of 5% or greater" compared with 19% of patients in the placebo arm (P<0.001), and 17% achieved weight loss of 10% or more versus 8% in the placebo arm (P<0.001).
Moreover, after two years, patients taking 20 mg of Acomplia were able to maintain a waist measurement that was about two inches smaller than baseline measurements, compared with a reduction of just 0.87 inches for those in the placebo arm (P<0.001).

Nonetheless, a high attrition rate — 51% dropped out after a year — led F. Xavier Pi-Sunyer, M.D., of the obesity center at St. Luke’s-Roosevelt Hospital in New York and colleagues to conclude that more study is needed to finally confirm a long-term benefit for Acomplia, which is the first cannabinoid-1 receptor blocker.

Rimonabant was discovered in Sanofi laboratories in France. More than 200 employees in Malvern supervised the clinical trials and worked on regulatory submissions to the FDA. Company executives, who have been in discussions with the FDA about approval of Acomplia, had not disclosed what medical indications the FDA might approve for the drug’s label. Just how successful Acomplia will be will depend on the medical conditions of use the FDA agrees to and whether users will be reimbursed by governments and health insurers. The company will need to persuade regulators that Acomplia reduces cardiovascular risk factors for diabetes and heart disease, because a weight-loss label alone may not be enough to qualify for reimbursement by health plans.
Source: Sanofi-aventis

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DID YOU KNOW:
20 to 50% of women with gestational diabetes will develop Type 2 diabetes within 5 to 10 years of Pregnancy: Infants of women who develop gestational diabetes are usually are not affected by the condition, but some infants born to these women develop jaundice, have low blood sugar at birth, are at an increased risk for obesity and are at an increased risk of developing Type 2 diabetes as an adolescent or adult. According to the Times, two trends that "seem to be colliding to push up prevalence" of the condition are that many women are entering pregnancy overweight and more women are giving birth at a later age (Kleinfield, New York Times, 2/18).