Who manufactures MYALEPT?

Myalept is a recombinant analogue of human leptin, indicated in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy….AstraZeneca to divest Myalept to Aegerion.

Is MYALEPT a biologic?

Myalept™ (metreleptin for injection) is a recombinant human leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy….Contacts:

What is Metreleptin used for?

Metreleptin injection is used together with a proper diet as replacement therapy to treat problems caused by leptin deficiency in patients with congenital or acquired generalized lipodystrophy. This medicine is only available under a restricted distribution program called Myalept® REMS program.

What is generalized lipodystrophy?

Summary. Congenital generalized lipodystrophy (CGL), also known as Berardinelli-Seip syndrome, is a rare genetic disorder characterized by the near total loss of body fat (adipose tissue) and extreme muscularity that is often present at birth or soon thereafter.

How is Myalept administered?

Instructions. Inform patients that each vial of MYALEPT requires reconstitution with BWFI or preservative-free WFI, and administration as subcutaneous injection using a syringe and needle. Injections can be given at any time of the day, with or without meals.

Is Metreleptin approved?

AstraZeneca today announced the US Food and Drug Administration (FDA) approved 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 generalised lipodystrophy.

How many people have CGL?

Approximately 500 patients with CGL have been reported in the medical literature. The estimated worldwide prevalence is approximately 1 in 10 million individuals in the general population. The disorder has been reported in individuals of every ethnic group.

What is the life expectancy of someone with lipodystrophy?

Age at death (years-old) of Berardinelli-Seip Congenital Lipodystrophy patients according to the year of death. Life expectancy for the study population was 62.9±4.8 years. The potential number of years of life lost was 35.6±16.6 years.

How do you fix lipodystrophy?

There are ways to manage lipodystrophy. Making dietary changes and getting regular exercise may help to build muscle and reduce abdominal fat. Liposuction (surgical removal of fat) and injectable facial fillers are sometimes used to treat lipodystrophy.

What is leptin deficiency?

Leptin receptor deficiency is a condition that causes severe obesity beginning in the first few months of life. Affected individuals are of normal weight at birth, but they are constantly hungry and quickly gain weight. The extreme hunger leads to chronic excessive eating (hyperphagia) and obesity.

What is Myalept used for?

Myalept is a prescription medicine used with a diet recommended by your healthcare provider to treat problems caused by not having enough leptin in your body (leptin deficiency) in people with congenital or acquired generalized lipodystrophy.

Why is Myalept available only through a restricted distribution program?

Myalept is available only through a restricted distribution program under a REMS, called the Myalept REMS Program, because of the risks associated with the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or Myalept and the risk for lymphoma [see Warnings and Precautions (5.1, 5.2) ].

Can Myalept be reconstituted aseptically?

Myalept can be reconstituted aseptically with 2.2 mL of sterile Bacteriostatic Water for Injection (BWFI), USP (0.9% benzyl alcohol), or with 2.2 mL of sterile Water for Injection (WFI).

Is Myalept safe for newborns or infants?

When Myalept is used in newborns or infants, Myalept should be mixed with sterile water for injection (WFI). Talk to your healthcare provider about any side effect that bothers you or that does not go away.