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news.AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its orphan drug Myalept (metreleptin for injection), which is indicated as an adjunct to diet as replacement therapy for the treatment of complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
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Myalept, an analogue of leptin made through recombinant DNA technology, is the first and only treatment approved by the FDA for these patients.
The company is currently working to complete the transfer of the Biologics License Application (BLA) for Myalept from Bristol-Myers Squibb (BMS) to AstraZeneca as part of the acquisition of the diabetes alliance assets, including Myalept and Amylin Pharmaceuticals, which was completed on 01 February 2014.
Generalized lipodystrophy is a condition related with a lack of fat tissue, which causes a deficit in the hormone leptin leading to multiple metabolic complications.
In some patients lipodystrophy is genetic, while in others it may be acquired for different pathophysiological, and in some cases unknown, reasons.
The company said that safety and effectiveness of Myalept for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including non-alcoholic steatohepatitis (NASH), have not been established.
The drug is not indicated for use in patients with HIV-related lipodystrophy or for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridaemia, without concurrent evidence of congenital or acquired generalised lipodystrophy.
Myalept, which is for subcutaneous injection only, is available in an 11.3mg vial that requires reconstitution.
It is contraindicated in patients with general obesity not associated with congenital leptin deficiency.
Image: AstraZeneca’s Myalept is for subcutaneous injection only and is available in an 11.3mg vial that requires reconstitution. Photo: courtesy of Baitong333/ freedigitalphotos.net