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Kythera Biopharmaceuticals, Inc submits new drug application for ATX-101 as first in class treatment for reduction of submental fat

Monday, 12 May 2014 07:30pm EDT 

Kythera Biopharmaceuticals, Inc:Says that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, 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.Chief medical officer says since the company began evaluating ATX-101 through global clinical development program, it has demonstrated positive results in reducing fat under the chin, paired with an excellent safety profile and high patient satisfaction.Beyond this NDA submission, KYTHERA also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015. 

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19 Dec 2014