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FDA panel backs Kythera's double-chin treatment

March 10, 2015 2:17 AM UTC

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted 17-0 to back approval of ATX-101 deoxycholic acid from Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH) to reduce submental (under chin) fat. The injectable synthetic sodium deoxycholate has a May 13 PDUFA date. Kythera plans to launch the compound in 2H15, if it is approved. The company said ATX-101 would be the first approved non-surgical method of reducing submental fat.

In Bayer AG (Xetra:BAYN) (see BioCentury Extra, March 10, 2014). ...