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Slight dent for Amylin seeking US approval of metreleptin for lipodystrophy

This article was originally published in Scrip

Executive Summary

Amylin Pharmaceuticals has revealed in a regulatory filing that the US FDA is seeking some updated data that relate to its rolling biologics license application (BLA) for metreleptin, an analogue of the human hormone leptin, which is under investigation to treat lipodystrophy, a rare metabolic disorder. Amylin said the regulator seeks updated data from the submitted clinical studies that remain ongoing.



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