The Food and Drug Administration on April 29 approved deoxycholic acid (DCA) injection for the treatment of submental fat.
The cytolytic agent, a synthetic version of naturally occurring DCA, physically destroys fat cells when injected properly into submental fat. It is the first drug approved for the treatment of submental fat, and it received unanimous support from an FDA advisory panel in March based on two placebo-controlled phase III trials involving more than 1,000 adults.
The studies demonstrated the safety and effectiveness of treatment with up to 50 injections of 0.2 mL of the 1% DCA solution administered in a single treatment. Up to six treatments can be administered at least 1 month apart.
Serious side effects associated with injection of DCA may include nerve injury in the jaw and trouble swallowing, but the most common side effects are swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.
DCA will be marketed as Kybella by Kythera Biopharmaceuticals.
“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,” Dr. Amy G. Egan, deputy director of the Office of Drug Evaluation III in the FDA Center for Drug Evaluation and Research said in the statement announcing the approval.
Kybella will be provided in single-patient–use vials and should not be diluted or mixed with other compounds. The dispensing pack has a unique hologram on the vial label, and the product should not be used if there is no hologram.
Physicians and patients are encouraged to report adverse reactions from the use of Kybella to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-FDA-1088.
