KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
Submental fullness due to submental fat, sometimes referred to as ”double chin,” is a common, yet undertreated facial aesthetic condition. It can detract from an otherwise balanced and harmonious facial appearancei – leading to an older and heavier look. Submental fullness can impact a broad range of adults, and is not limited to people who are overweight. This condition can impact men or women of average weight and can be caused by aging, genetics and weight gain. It is often resistant to diet and exercise alone. According to a 2014 survey by the American Society for Dermatologic Surgery (ASDS), over 2/3 of consumers are bothered by submental fullness – nearly as many as those bothered by lines and wrinkles around the eyes.
KYBELLA™ (deoxycholic acid) injection, also known as ATX-101, is the first and only FDA-approved injectable drug that contours and improves the appearance of submental fullness due to submental fat. KYBELLA™ is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. The safe and effective use of KYBELLA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
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.iv Once destroyed, those cells cannot store or accumulate fat. After the aesthetic response is achieved, retreatment with KYBELLA™ is not expected. Due to its cytolytic activity, KYBELLA™ should not be injected into or in close proximity to vulnerable anatomic structures.
KYBELLA™ is administered by injections into the fat under the chin. Each in-office treatment session is typically 15-20 minutes. Treatment with KYBELLA™ is customized by the physician to the patient’s aesthetic goals for an improved chin profile.
In the pooled, pivotal Phase III studies, 68.2 percent of patients responded to KYBELLA™ based on a composite of validated physician and patient measurements. Many patients experienced visible results in two to four treatments. KYBELLA™ treatment resulted in high patient satisfaction. In clinical studies, 28%, 43% and 55% of KYBELLA™ treated patients had a ≥1-grade composite improvement after 2, 3 and 4 treatments, respectively. Patients also reported improvement in the emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.
KYBELLA™ has been the focus of a global clinical development program involving over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™. Production of KYBELLA™ is a highly controlled, quality-assured and validated, current Good Manufacturing Practices-compliant process to ensure patient safety. KYBELLA™ contains no human or animal-derived substances.
The safety profile of KYBELLA™ is well characterized. Side effects may include swelling, bruising, pain, numbness, redness or formation of small areas of firmness. Adverse events with KYBELLA™ infrequently resulted in discontinuation from study (1.6% of participants). Care must be taken when injecting KYBELLA™ to avoid the risk of marginal mandibular nerve injury and dysphagia.