Kythera Biopharmaceuticals Inc. has submitted a new drug application for approval of its novel treatment for the elimination of chin fat.
The Calabasas company has spent seven years in clinical trials for ATX-101, an injectable acid that reduces double chins and is designed to replace cosmetic surgery. Two critical trials in late 2013 provided data for submission to the Food and Drug Administration for approval to commercialize ATX-101.
“In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment,” the company reported.
In addition to the FDA submission, Kythera plans to make multiple regulatory submissions outside the U.S. by the middle of next year.
In March, the company announced it had acquired the right to sell ATX-101 outside of the United States and Canada from Bayer Consumer Care AG, to which it had licensed the foreign rights for ATX-101 in 2010.
Kythera announced the FDA submission after markets closed Monday.
Shares, which had been rising the past few days in anticipation of the announcement, fell $1.11, or more than 3 percent, to $33.32 on the Nasdaq in apparent profit taking.