KYTHERA files for EU approval of 'double-chin' treatment

18 August 2015

KYTHERA Biopharmaceuticals (Nasdaq: KYTH) has submitted a Marketing Authorization Application (MAA) in the European Union, seeking approval for ATX-101 (deoxycholic acid) injection as a treatment for the reduction of submental fat when the presence of submental fat, also referred to as double chin, 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.

ATX-101 was approved by the US Food and Drug Administration in April 2015 (under the name Kybella) and received authorization from Health Canada in July 2015 (under the name Belkyra). In addition to the regulatory filing for ATX-101 in the European Union, KYTHERA has submitted regulatory filings in Switzerland and Australia.

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