Myalept approved for rare fat tissue disorder

(HealthDay)—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 , 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 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 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 , 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.

More information: The FDA has more about this approval.

add to favorites email to friend print save as pdf

Related Stories

Blood sugar monitoring system approved for children

Feb 04, 2014

(HealthDay)—U.S. Food and Drug Administration approval of the Dexcom G4 Platinum Continuous Monitoring System has been expanded to include children with diabetes aged 2 years to 17 years, the agency said.

Vimizim approved for rare childhood disorder

Feb 17, 2014

(HealthDay)—Vimizim (elosulfase alfa) has been approved by the U.S. Food and Drug Administration to treat a rare childhood disorder called Mucopolysaccharidosis Type IVA, also known as Morquio A syndrome.

Tretten approved for genetic clotting disorder

Dec 23, 2013

(HealthDay)—Tretten (coagulation factor XIII A-Subunit recombinant) has been approved by the U.S. Food and Drug Administration to treat a very rare blood clotting disorder called congenital Factor XIII A-Subunit deficiency.

Northera approved for rare blood pressure condition

Feb 19, 2014

(HealthDay)—Northera (droxidopa) has been approved by the U.S. Food and Drug Administration to treat a rare, chronic condition characterized by a sudden drop in blood pressure when a person stands.

Stent to treat pancreatic cysts approved

Dec 19, 2013

(HealthDay)—The Axios Stent and Delivery System has been approved by the U.S. Food and Drug Administration to treat infected pancreatic cysts that won't drain on their own and could become life threatening, the FDA said ...

Recommended for you

Journal raises concern about blood-thinning drug

1 hour ago

A medical journal raised concerns Wednesday about a blood-thinning drug widely used by people at risk of stroke, accusing its manufacturer of concealing safety data and regulators of laxness.

Supermaterial gives rejected drugs a new chance

Jul 22, 2014

More than 80 percent of all drug candidates in the pharma R&D suffer from poor solubility and are therefore rejected early in the drug discovery process. Now Uppsala University researchers show that the new ...

Risk of antibiotic overuse in aged care settings

Jul 21, 2014

Antibiotics are being overused in residential aged care facilities (RACFs), and more integrated efforts to improve antibiotic prescribing practices need to be introduced, researchers say. 

User comments