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news.The US Food and Drug Administration (FDA) has accepted for filing Kythera Biopharmaceuticals' new drug application (NDA) for ATX-101 (deoxycholic acid).
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The company said that ATX-101 NDA, which was submitted in May 2014, will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of 13 May 2015.
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.
At present, ATX-101 (deoxycholic acid) is 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 that the company is happy that its NDA filing has been accepted by the FDA, representing another significant corporate milestone.
"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," Leonard added.
A formulation of a purified synthetic version of deoxycholic acid, ATX-101 destroys fat cells and contours the area under the chin.
Currently, 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 program enrolled over 2,500 patients worldwide, of which more than 1,500 have been treated with ATX-101.