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FDA slims obesity pill chances

This article was originally published in Scrip

Executive Summary

In issuing a complete response letter (CRL) to i today and requesting a further clinical study that assesses the cardiovascular risks to obese patients, the FDA not only went against the recommendations of its own Advisory Panel, but probably delivered the kiss of death to a tablet-based approach to treating obesity in the primary care setting for the foreseeable future. Having raised pre-clinical safety issues for Qnexa from Vivus in late January and having issued a CRL to Arena Pharmaceuticals' Lorcaserin last year asking for additional safety and efficacy information, Orexigen's drug was previously the last left standing in the approval queue that is now effectively empty.

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