Pharmaceutical company Allergan has received a positive opinion from Sweden’s Medical Products Agency (MPA) for Belkyra (deoxycholic acid) to treat moderate to severe convexity related to submental fat in adults when it affects patients psychologically.
Submental fullness or double chin is an undertreated condition whereby fat grows under the chin or neck of a person, thereby often giving an older or heavier look.
Allergan Research and Development (R&D) chief officer David Nicholson said: "We are delighted to receive the positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra, which provides men and women who are bothered by submental fullness with a new minimally invasive treatment option.
"Because of the extensive evidence behind the product, we see Belkyra as a breakthrough treatment that will complement other aesthetic treatments."
On receiving approval, Belkyra will be the first prescription medicine to be licensed in Europe for the treatment of double chin.
Belkyra is currently being assessed through the Decentralised Procedure, with the Swedish MPA acting as the reference member state for 20 other countries in the European Union (EU), along with Iceland and Norway.
Fullness under the chin or a double chin is wrongly believed to appear only on those who are overweight, whereas, in reality a person with any body type may have a double chin.
Double chin can also be related to aging, genetics or weight gain.
As a next step, Allergan will work to receive the national marketing authorisations in the concerned member states.
Belkyra is already licensed for use within Canada and the US as Kybella.