FDA approves ATX-101 for treatment of submental fat
The FDA announced today it has approved Kybella, also known as ATX-101, for the treatment of moderate-to-severe submental fat in adults.
Kybella (deoxycholic acid, Kythera Biopharmaceuticals) is not approved nor recommended for treating fat outside the submental area, according to an FDA press release.
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with the use of the drug before considering treatment,” Amy G. Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. “It is important to remember that Kybella is only approved for treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
ATX-101 is a cytolic drug, which physically destroys the cell membrane when injected into tissue, according to the release. The drug destroys fat cells when properly injected into submental fat; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered less than 1 month apart, the FDA release stated. Results of two clinical trials including 1,022 adult participants with moderate-to-severe submental fat were used to establish the safety and effectiveness of the treatment.
Side effects include nerve injury to the jaw that can cause an uneven smile or facial muscle weakness, as well as trouble swallowing, according to the release. Common side effects include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment areas.
An FDA advisory committee recommended ATX-101 approval in March.
References: www.fda.gov, www.kythera.com.