Amylin seeking first US approval for lipodystrophy with metreleptin
This article was originally published in Scrip
Executive Summary
Amylin Pharmaceuticals’ completion of its rolling biologics license application (BLA) with the US FDA for metreleptin – an analogue of the human hormone leptin, which is under investigation to treat lipodystrophy, a rare metabolic disorder – is more evidence the company is a fighter when it comes to bringing its diabetes-related products to the US marketplace, letting a minor manufacturing setback last fall not stand in its way.