Acomplia News
In April 2007, it was announced that Acomplia would be marketed under the name Zimulti, pending the drugs approval in the United States. Previously, Acomplia developers Sanofi-Aventis were reluctant to share the intended name.
In a meeting notice published by the FDAs Endocrinologic and Metabolic Drugs Advisory, it was reported that some suggestions made by Sanofi-Aventis financial analysts were omitted, such as Acomplias proposed treatment of Type II Diabetes. In the meetings published notice, the FDA was said to consider Acomplia only "as an adjunct to diet and exercise for obesity management in patients with a body mass index equal to or greater than 30, or a body mass index equal to or greater than 27 if accompanied by at least one cardiovascular risk factor."
According to the German state insurance system, Acomplia is a lifestyle drug and as such, is not eligible for patients who seek reimbursement for the drugs purchase. The French government, however has approved partial coverage, but only for those patients who have been diagnosed as obese and who also suffer from Type II diabetes which is not being adequately controlled.
On March 29th, 2007, it was announced by Sanofi-Aventis that on June 13th, the sale of Acomplia in the U.S. would be discussed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee. The discussion addressed safety concerns and the effectiveness of Acomplia for improved weight loss and blood lipid profiles. A spokesman for Sanofi-Aventis stated that this meeting would not jeopardize FDA approval, expected to occur on July 26th.
On March 22nd, 2007, the French government announced that it would approve reimbursement for 35% of Acomplias cost by health insurance agencies and state social security. However, the announcement stated reimbursement approval for obese and Type II diabetes only, and only where other treatments have proved insufficient.
On February 6th, 2007, Acomplia received a favourable response and recommendation for reimbursement by Frances health insurance and social security agencies. The recommendation was extended only to patients suffering from obesity and diabetes, and the French Government had yet to state the portion of the cost that would be refunded.
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