Sanofi's Adlyxin Merely Another Option For Type 2 Diabetes Treatments
After a long wait, lixisenatide has little to distinguish itself from the five GLP-1 products already on the market.
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Who says an advisory committee stop is a risky proposition? FDA’s advisors have voted in favor of approval on each of the last 12 products they’ve reviewed.
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Using a clinical trial originally designed for safety to support an efficacy superiority claim poses unique challenges that can make reliance upon a single study for regulatory purposes potentially risky.