FDA approves Kybella (sodium deoxycholate) for Submental Fat reduction- Kythera Biopharma

The FDA has approved Kybella (sodium deoxycholate), from Kythera Biopharmaceuticals, also known as ATX-101, for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. Kybella is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition.

The application was supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with Kybella. In the pivotal Phase III studies, 68.2 percent of patients responded to Kybella based on a composite of validated physician and patient measurements.ii Patients treated with Kybella reported an improvement in the amount of fat in the area under the chin. 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.

The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of small areas of firmness around the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent.