Kythera Biopharmaceuticals submits marketing authorisation application in the European Union for ATX-101 as first-in-class treatment for the reduction of submental fat

18 August 2015 - Kythera Biopharmaceuticals, Inc. announced today it has submitted a Marketing Authorisation 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 Decentralised 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 that can detract from an otherwise balanced and harmonious facial appearance – leading to an older and heavier look.

For more details, go to: http://www.kythera.com/kythera-biopharmaceuticals-submits-marketing-authorization-application-in-the-european-union-for-atx-101-as-first-in-class-treatment-for-the-reduction-of-submental-fat/

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Europe , Registration , EMA