Allergan's Belkyra (deoxycholic acid) has received marketing authorisation in Sweden for the treatment of moderate to severe fullness under the chin, often called double chin, in adults.
Approved by the Swedish Medical Products Agency (MPA), Belkyra is developed as an individually tailored, non-surgical injectable treatment for moderate-to-severe convexity or fullness associated with submental fat.
The prescription medicine is injected into fat under the chin to permanently destruct fat cells, which cannot restore or accumulate fat once destroyed.
Allergan chief commercial officer Bill Meury said: "Belkyra provides physicians with one of the first clinically evaluated and approved treatments for their patients who are bothered by fullness under the chin.
"We believe Belkyra will be a breakthrough treatment in Europe as it has been in the US and Canada, and it complements our established medical aesthetics portfolio.”
Over the coming months, the medicine is expected to be introduced in other European countries once the company receives the additional approvals.
Belkyra has completed a clinical evaluation, including four Phase III clinical studies involving more than 2,600 patients worldwide.
Two Phase III clinical studies in North America and two in Europe evaluated the safety of the medicine in adults with moderate-to-severe fullness under the chin.
The studies showed that Belkyra has a high overall efficacy rate, demonstrated by a one-grade improvement in fullness under the chin as assessed by the clinician in the study at 12 weeks after completing the last treatment.
Belkyra was evaluated through a decentralised procedure and is already licensed as Kybella in the US, Canada, Australia, Iceland, Hungary, Austria, Lithuania, Estonia, Latvia, Romania, Bulgaria and Norway.