FDA Approves AstraZeneca-BMS Drug Myalept for Lipodystrophy

The Food and Drug Administration Feb. 25 said it approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency in patients with lipodystrophy.

The approval was dated Feb. 24, the agency said. Myalept is marketed by San Diego-based Amylin Pharmaceuticals, which is part of Bristol-Myers Squibb. Bristol-Myers is marketing the drug with AstraZeneca.

Because of the risks of the drug, it is available only through a risk evaluation and mitigation strategy, or REMS, program, the agency said.

“Myalept is the first approved therapy indicated for treating the complications associated with congenital or acquired generalized lipodystrophy ...