FDA Approves Myalept to Treat Lipodystrophy Complications

The U.S. Food and Drug Administration has approved Myalept, metreleptin for injection, as a treatment option for patients with congenital generalized or acquired generalized lipodystrophy.

Lipodystrophy is a condition where patients have little to no fat tissue. Patients with lipodystrophy have low leptin levels, as leptin is produced by fat tissue.  

When combined with a certain diet, Myalept, marketed by San Diego-based Amylin Pharmaceuticals, can treat complications with this condition.

The most common side effects observed during clinical trials were headaches, low blood sugar, decreased weight and abdominal pain.

Currently, Myalept is only available through the Myalept Risk Evaluation and Mitigation Strategy Program.

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