Kythera Biopharmaceuticals files MAA in European Union for ATX 101 (deoxycholic acid) to reduce submental fat (double chin)

Kythera Biopharmaceuticals, Inc. announced it has submitted a Marketing Authorization Application (MAA) in the European Union (EU), seeking approval for ATX-101 (deoxycholic acid) injection as a treatment for the reduction of submental fat when the presence of submental fat has a psychological impact for the patient.

The MAA was submitted via the Decentralized Procedure with Sweden as the Reference Member State and is supported by results from four pivotal Phase III trials conducted in Europe and North America. More than 1,500 patients participated in these trials with 757 patients treated with ATX-101. Submental fullness, also referred to as double chin, is a common yet under-treated condition.

ATX-101 is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with ATX-101. In the pivotal Phase III trials conducted in Europe, more ATX-101-treated patients (63.8%) showed at least a 1-grade improvement on the clinician's submental fullness rating scale than did placebo-treated patients (28.6%). Additionally, more ATX-101-treated patients reported satisfaction with outcome (65.4%) and a greater reduction in the psychological impact of submental fullness (44.7%) than did placebo-treated patients (29.0% and 14.1%, respectively).In the pivotal Phase III trials conducted in North America, 68.2% of patients responded to ATX-101 based on a composite of validated physician and patient measurements compared to 20.5% in the placebo group. Patients also reported improvement in the psychological impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.

Comment: ATX 101 was FDA approved as Kybella in April 2015.