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Allergan's Lap-Band AP approved in Europe for diabetes

This article was originally published in The Gray Sheet

Executive Summary

Adjustable gastric banding system for obesity intervention becomes the first such device to gain European market approval for weight loss that leads to improvement or remission of type 2 diabetes, the firm announces June 26. The approval was supported by results of a two-year randomized trial that confirmed results from previous observational studies. The study showed that patients who lost weight with Lap-Band AP were over five-times more likely to achieve remission of type 2 diabetes than patients receiving conventional diabetes therapy (73% vs. 13%). Expanded labeling for the device states that weight loss associated with the system "has been shown to improve or lead to remission of type 2 diabetes," the company says

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