FDA OKs Kythera’s Drug for Treating Double Chin
The US Food and Drug Administration (FDA) has approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Kybella is manufactured by Kythera Biopharmaceuticals Inc. based in Westlake Village, California.
Kybella is an injectable drug for contouring moderate to severe submental fullness, a condition that is commonly referred to as a double chin. Kybella is a non-human and non-animal formulation of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, Kybella causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat.ii
Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
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 provided in single-patient use vials and should not be diluted or mixed with any other compounds.