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AstraZeneca's lipodystrophy drug Myalept OK'd in US; FDA wants 15 studies

This article was originally published in Scrip

Executive Summary

The FDA on 25 February gave its OK for AstraZeneca’s Myalept (metreleptin for injection) to enter the US market as an adjunct to diet to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy, a rare disease that causes a loss of fat tissue, especially under the skin, resulting in a deficit of the hormone leptin.

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