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.

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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.

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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.