WASHINGTON -- An injection to reduce accumulations of submental fat -- better known as double chin -- is safe and effective and can be marketed for the indication, .
To be sold as Kybella, the synthetic deoxycholic acid agent was developed by Kythera Pharmaceuticals of Westlake Village, Calif.
Deoxycholic acid is an endogenous substance that, in normal physiology, helps the body absorb fat. When injected into tissues it dissolves cell membranes.
For the submental fat reduction indication, Kythera's synthetic version may be injected in up to 50 locations during a single treatment, and patients may receive up to six treatments at least 1 month apart, the FDA said in announcing the approval.
"Treatment with Kybella should only be provided by a licensed healthcare professional, and patients should fully understand the risks associated with use of the drug before considering treatment," said Amy G. Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, in a statement. "It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area."
Adverse effects seen in clinical trials included nerve injury in the jaw that can cause facial muscle weakness, asymmetrical facial expressions, and trouble swallowing. The most common side effects were swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area, the FDA said.
Effectiveness was demonstrated in two placebo-controlled clinical trials enrolling 1,022 patients, which showed that those receiving the active drug more often showed reductions in double-chin appearance.
An FDA advisory committee voted last month to recommend approval, deciding that the drug's benefits outweighed the risks as long as patients were adequately informed. But panel members expressed concern about possible off-label use to reduce fat elsewhere in the body, the effects of which have not been studied.