FDA Clears Deoxycholic Acid (Kybella) for Double Chins

Megan Brooks

Disclosures

April 29, 2015

The US Food and Drug Administration (FDA) today approved deoxycholic acid (Kybella, Kythera Biopharmaceuticals) to help reduce double chins.

The approval follows a unanimous vote on March 9 by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee in favor of deoxycholic acid injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Kybella is a patented formulation of a pure, nonanimal-derived version of deoxycholic acid, which is an endogenous molecule that aids in the breakdown of dietary fat. Once injected, Kybella physically disrupts the cell membrane, causing the destruction of fat cells. However, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin, according to a news release from the FDA.

"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," Amy G. Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, advised.

"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," she said.

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 1 month apart, the FDA said. Kybella is provided in single-patient-use vials and should not be diluted or mixed with any other compounds.

The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials involving 1022 adults with moderate or severe submental fat who were randomly assigned to receive either Kybella or placebo for up to six treatments.

In both trials, at 12 weeks after the last treatment, 13% to 19% of patients who received Kybella had at least a two-grade improvement on both the Clinician-Reported Submental Fat Rating Scale and the Patient-Reported Submental Fat Rating Scale compared with 3% of patients who received placebo. At least 70% of patients who received Kybella had at least a one-grade improvement.

Those scales were developed and validated by Kythera in conjunction with the FDA. The agency said both efficacy measures were statistically significant.

Kybella also led to statistically significant improvement on two secondary endpoints: magnetic resonance imaging scans of fat reduction and a patient-rated overall appearance scale that was also developed by Kythera.

The FDA notes that Kybella can cause serious adverse effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness and trouble swallowing. The most common adverse effects of Kybella include swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area. The FDA says caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.

Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. "If there is no hologram, do not use the product," the FDA warns.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....