KYTHERA Biopharma gets FDA approval for double-chin treatment Kybella

The US Food and Drug Administration has approved KYTHERA Biopharmaceuticals’ (Nasdaq: KYTH) Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.

Kybella, also known as ATX-101, is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition. The product was previously being developed with German pharma major Bayer (BAYN: DE), but the company returned rights to KYTHERA last year (The Pharma Letter March 11, 2014). Bayer is eligible to receive certain long-term sales milestone payments on annual sales outside of the USA and Canada.

"For the first time, people have access to an FDA-approved, non-surgical treatment for submental fullness, a condition that can negatively impact the overall appearance of the face and can result in a person feeling older and heavier," said Keith Leonard, president and chief executive Officer of KYTHERA, adding: "With Kybella, physicians can offer a clinically-proven treatment that is customized to the patient and their treatment goals for an improved chin profile. Importantly, Kybella treatment resulted in high patient satisfaction."