FDA accepts Kythera’s ATX-101 new drug application

Kythera Biopharmaceuticals’ new drug application (NDA) for its ATX-101, a submental contouring injectable drug, has been accepted for filing by the US Food and Drug Administration (FDA).

According to Kythera Biopharmaceuticals, the ATX-101 NDA will be subject to a standard review and will have a prescription drug user fee act (PDUFA) action date of 13 May 2015. The company submitted the NDA in May 2014.

The FDA’s Division of Dermatology and Dental Products is also planning to hold an Advisory Committee meeting on the company’s ATX-101 application during the review.

“While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area under the chin.”
ATX-101 (deoxycholic acid) is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat, the company claims.

Kythera Biopharmaceuticals president and CEO Keith Leonard said: “While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area under the chin.”
A formulation of a purified synthetic version of deoxycholic acid, ATX-101 destroys fat cells and contours the area under the chin.

As present, the potential submental contouring injectable drug is in late-stage clinical trials. ATX-101 has been the focus of a global clinical development programme for the past seven years.

The global clinical development programme enrolled over 2,500 patients worldwide, of which more than 1,500 have been treated with ATX-101.