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The US Food and Drug Administration (FDA) has approved AstraZeneca’s Myalept (metreleptin for injection) as replacement therapy for the treatment of complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy.

An analogue of leptin made through recombinant DNA technology, Myalept is presently the only treatment approved by the US FDA for patients with lipodystrophy.

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The company is seeking to complete the transfer of the biologics licence application (BLA) for the drug from Bristol-Myers Squibb (BMS) as part of the acquisition completed in this month for the diabetes alliance assets, including Myalept and Amylin Pharmaceuticals.

Generalised lipodystrophy is characterised by widespread loss of fat tissue under the skin, which causes a deficit in the hormone leptin leading to multiple metabolic complications.

Safety and effectiveness of the drug for treatment of complications of partial lipodystrophy or for treating liver disease, including non-alcoholic steatohepatitis (NASH), have not been established.

The drug is not approved for patients with HIV-related lipodystrophy or in patients with metabolic disease, including diabetes mellitus and hypertriglyceridaemia, without concurrent evidence of congenital or acquired generalised lipodystrophy.

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“Myalept is the first approved therapy, as an adjunct to diet, to help treat the complications of leptin deficiency.”

The company said that Myalept will only be available via FDA’s risk evaluation and mitigation strategy (REMS) programme, which requires prescriber and pharmacy certification and special documentation.

AstraZeneca executive vice-president of global medicines development and chief medical officer Briggs Morrison said: “Myalept is the first approved therapy, as an adjunct to diet, to help treat the complications of leptin deficiency affecting the lives of children and adults with generalised lipodystrophy.

“Myalept represents a significant treatment advancement for people living with this serious and rare disorder.

“We are committed to supporting this patient community and are dedicated to ensuring the appropriate patients who are prescribed Myalept will also have a comprehensive patient support programme available to them.”

Myalept is intended for subcutaneous injection only and is available in a 11.3mg vial that requires reconstitution.

The drug is contraindicated in patients with general obesity not associated with congenital leptin deficiency.

Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca.