FDA approves Kythera's double-chin injection
- Kythera's Kybella, also known as ATX-101, has been approved for use in improving the appearance of submental fat in adults.
- Kybella is a nonsurgical treatment—the very first nonsurgical treatment for reducing the appearance of submental fat, or double-chin.
- Kybella is an injectable treatment, which involves a total of up to six visits, lasting 15 to 20 minutes at a time.
The approval of Kybella is based on a large-scale clinical development program, which includes more than 20 clinical trials and 2,600 patients. In phase III studies, 68.2% of patients responded to Kybella based on a composite of physician and patient responses.
For patients, the physical improvements correlated with a high level of satisfaction and overall positive emotional response. Kybella is being launched into a robust marketplace in which Americans are spending more than $12 billion per year for cosmetic procedures, and are actively looking for non-surgical options. And with 68% of patients reporting feeling bothered by fat under their chin, there will most likely be robust product uptake post-launch.
- streetinsider.com Kythera Biophrarma (KYTH) Confirms FDA Approval of ATX-101