Myalept Approved for Rare Fat Tissue Disorder
TUESDAY, Feb. 25, 2014 -- Myalept (metreleptin for injection) has been approved by the U.S. Food and Drug Administration to treat complications of leptin deficiency for people with the congenital or acquired generalized forms of lipodystrophy.
The disorder is associated with a lack of fat tissue. Leptin, produced by fat tissue, is a hormone that helps regulate food intake and other hormones such as insulin, the FDA said Tuesday in a news release.
People with lipodystrophy are at greater-than-average risk of developing serious insulin resistance at a young age, making them more prone to out-of-control diabetes and high levels of blood fats called triglycerides.
Myalept was evaluated in a clinical study of 48 people with generalized lipodystrophy and its complications. The trial showed good results in blood sugar control and reduced blood triglycerides, the FDA said.
People taking Myalept may develop a resistance to the drug, making it less effective over time and increasing their risk of severe infection, the agency said.
Less serious side effects could include low blood sugar, headache, weight loss and abdominal pain. The drug is not recommended for people with general obesity.
The FDA said it has ordered a number of post-marketing studies to further evaluate the drug and its potential to cause serious side effects.
Myalept is marketed by Amylin Pharmaceuticals, based in San Diego.
The FDA has more about this approval.
Posted: February 2014