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FDA Accepts Kythera Drug for Review

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.

Joel Russel
Joel Russel
Joel Russell joined the Los Angeles Business Journal in 2006 as a reporter. He transferred to sister publication San Fernando Valley Business Journal in 2012 as managing editor. Since he assumed the position of editor in 2015, the Business Journal has been recognized four times as the best small-circulation tabloid business publication in the country by the Alliance of Area Business Publishers. Previously, he worked as senior editor at Hispanic Business magazine and editor of Business Mexico.

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