HOW DOES KYBELLA® WORK?
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. 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.
HOW IS KYBELLA® ADMINISTERED?
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
WHAT ARE THE RESULTS OF KYBELLA® CLINICAL TRIALS?
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.
IS KYBELLA® SAFE?
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.
WHEN WILL KYBELLA® BE AVAILABLE?
KYTHERA® Biopharmaceuticals has chosen to execute a training-led launch and developed a training program to educate physicians on the safe use of KYBELLA®, and its approved indication. Physician faculty education will begin in June 2015. KYBELLA® physician training programs will initiate in late summer. Physicians will be able to purchase KYBELLA® and treat their patients after they have been trained.