Pharmaceutical

FDA panel recommends approving diabetes treatment for obese patients

diabetes illus250x03 FDA panel recommends approving diabetes treatment for obese patientsA Food and Drug Administration (FDA) advisory panel has given a thumbs-up recommendation to Novo Nordisk’s type 2 diabetes drug liraglutide for the treatment of chronic obesity in patients with at least one weight-related health issue, such as hypertension or pre-diabetes.

Liraglutide, known commercially as Victoza, would be sold under the label Saxenda for the obesity indication if it is approved by the FDA. The agency is not required to follow the recommendations of its advisory panels, but it usually does.

The positive recommendation was based on a clinical trial in which patients were given 3 mg of liraglutide. About half of those patients lost at least 5 percent of their body weight. Another 22 percent lost more than 10 percent of body weight. If approved, Saxenda would likely come with a hefty price tag as much as five times more than already approved weight loss drugs.

The panel’s recommendation was based on a 14-1 vote in favor of approving the drug. The one nay-sayer was Dr.David Kelsen from the Memorial Sloan Kettering Cancer Center, who questioned cancer risks associated with use of the drug.

A recently released FDA report raised concerns about breast cancer in women who took the drug, however the study did not establish whether the drug played a role in cancer promotion or progression. Liraglutide has also been linked to higher resting heart rates and gallbladder-related problems.

Victoza, the type 2 diabetes treatment version of liraglutide has also been linked to an increased risk of thyroid cancer. Liraglutide is in a class of medications known as incretin mimetics, which include the type 2 diabetes drugs Januvia and Byetta. Those drugs are currently being investigated due to reports of acute pancreatitis and pancreatic cancer.

Source: Daily Mail