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Acomplia (Rimonabant) Gets French OK Limited to Obese Diabetics
Diet drug Acomplia (rimonabant) on Feb. 6th received a "'favorable recommendation" for reimbursement by French health insurance companies and state social security plans for use limited to obese patients with type 2 diabetes insufficiently controlled by customary diabetes drugs.
The independent Transparency Committee, however, apparently did not recommend reimbursement for patients who are overweight or obese but not diabetics, according to a terse announcement by Sanofi-Aventis.
"The patients who may benefit from a reimbursed prescription are those associating obesity (BMI greater than or equal to 30) with type 2 diabetes, insufficiently controlled by a mono-therapy of metformin or sulfonylurea, with a HbA1c level between 6.5 and 10," the Committee said.
The next step is for the French government to decide if it will follow this recommendation and then the proportion of the cost to be refunded.
While the limited scope of the French approval had to have been a disappointment for the French drugmaker, Sanofi gave no indication today whether it might appeal.
Germany has already classified Acomplia as a "lifestyle" treatment, and decided its health care system will not reimburse the cost of the diet drug. Sanofi has said it will appeal the German decision.
The U.S. Food and Drug Administration still has given no indication when it might make a decision on whether to allow sale of Acomplia in the United States. The diet drug is currently on the market in the UK, Germany, Denmark, Sweden, Finland, Norway, Ireland, Argentina and Austria.
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