FDA Panel Recommends Kythera Biopharma's Double-Chin Treatment

(RTTNews) - KYTHERA Biopharmaceuticals Inc. (KYTH) announced that the U.S. Food and Drug Administration's Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin. If approved, ATX-101 would be a first-in-class submental contouring injectable drug.

The committee's recommendation, although not binding, will be considered by the FDA as it continues its review of ATX-101. If approved by the FDA, KYTHERA anticipates launching ATX-101 in the second half of 2015.

ATX-101 is a patented formulation of a pure, non-animal derived version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. ATX-101 has been the subject of 19 clinical studies involving more than 2,600 patients covering a span of ages (19-65) and BMI (18-40).

A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in May 2014 and has a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. Additionally, KYTHERA has submitted regulatory filings in Canada, Switzerland and Australia. If approved, ATX-101 would be a less-invasive, non-surgical option for the treatment of submental fullness.

Submental fullness is an oft-cited, yet undertreated, condition that can detract from an otherwise balanced and harmonious facial appearancei - leading to an older and heavier look. Submental fullness can affect adults of all ages and weight. Influenced by multiple factors, including aging and genetics, submental fullness is often resistant to diet and exercise.

Separately, KYTHERA Biopharmaceuticals said that it has commenced an underwritten public offering of $125 million of shares of its common stock. All of the shares of the common stock to be sold in the offering will be offered by KYTHERA.

KYTHERA noted that it intends to use the net proceeds of the offering to fund the ongoing development and preparation for potential commercialization of ATX-101, and the balance for working capital and general corporate purposes, including research and development, which may include repayments of outstanding amounts under KYTHERA's credit facility.