Kythera Biopharmaceuticals Inc. announced that the Food and Drug Administration has accepted its application for ATX-101, an experimental drug that dissolves chin fat.
If approved, ATX-101 would be the Calabasas biotech’s first commercial product. According to the company, the FDA’s acceptance simply means the application is complete and ready for review by experts. The agency has a goal to finish the review by May 13, 2015.
Chief Executive Keith Leonard said the acceptance is a corporate milestone for Kythera.
“While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area,” he said in a statement. “If approved, ATX-101 will be the first non-surgical treatment.”
Kythera announced the FDA’s acceptance on Thursday. Shares closed Friday down $1.13, or 3.3 percent, to $33.50 on the Nasdaq.