- 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.v 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.
ABOUT KYTHERA BIOPHARMACEUTICALS, INC.
KYTHERA Biopharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. In addition to its lead product KYBELLA™, KYTHERA also licensed the worldwide rights to setipiprant, an early-stage potential treatment for hair loss.
KYTHERA’s longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. KYTHERA has submitted regulatory filings for ATX-101 in Canada, Switzerland and Australia. Find more information at www.kythera.com.
- 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 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.