Kythera Biopharmaceuticals has filed its ATX-101 jab in the European Union to reduce the presence of submental fat, otherwise known as double chin, when it has a psychological impact on the patient.
According to the firm, submental fullness 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.
ATX-101 (deoxycholic acid) is backed by a global clinical development programme including more than 2,600 patients worldwide, 1,600 of which have been treated with the fat buster.
In pivotal Phase III trials conducted in Europe, more ATX-101-treated patients (63.8%) showed at least a one-grade improvement on the clinician’s submental fullness rating scale than did placebo-treated patients (28.6%).
Also, 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% and 14.1%, respectively), Kythera said.
Most frequently reported side effects include injection site pain, oedema, swelling, anaesthaesia, nerve injury and pruritus.
The drug was approved in the US in April (under the name Kybella) and in Canada in July (under the name Belkyra). Kythera has also been submitted for approval in Switzerland and Australia.