FDA Approves Injection To Fight Double Chin

(RTTNews) - The U.S. Food and Drug Administration has approved injectable drug Kybella (deoxycholic acid) that is indicated for reducing under-the-chin fat or double chin.

Kybella, made by Kythera Biopharmaceuticals, Inc. (KYTH), causes fat cells under the chin to dissolve.

The injection is used as a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. However, Kybella is not approved or recommended for the treatment of fat outside of the submental area.

Kybella is a synthetic version of deoxycholic acid, which helps with the absorption of fat and is naturally produced in the body normally. Kybella is the first and only submental contouring injectable drug.

Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart.

Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. It is a cytolytic drug, which when injected into tissue physically destroys the cell membrane or fat cells. However, it can also destroy other types of cells, such as skin cells, if not injected properly.

"Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with use of the drug before considering treatment," said Amy G. Egan, M.D., M.P.H., deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat. The trial results showed more frequent reductions in submental fat in participants who received Kybella versus placebo.