ATX 101 submitted to FDA for Submental Fat Reduction-Kythera Biopharma

Kythera Biopharmaceuticals has submitted a New Drug Application (NDA) to the FDA for ATX 101 (deoxycholic acid) as an injectable treatment for Submental Fat Reduction, which commonly presents as a double chin. Positive and consistent results from two pivotal Phase III trials � REFINE-1 and REFINE-2 � were reported in late 2013 and provide the basis for the NDA submission. 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 also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015.