Myalept approved for rare fat tissue disorder

February 25, 2014

(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.

Explore further: Blood sugar monitoring system approved for children

More information: The FDA has more about this approval.

Related Stories

Blood sugar monitoring system approved for children

February 4, 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

February 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

December 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

February 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

December 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 ...

US approves diabetes drug with new approach (Update)

January 8, 2014
The U.S. Food and Drug Administration on Wednesday approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca that uses a novel approach to reduce blood sugar.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.