Allergan Korea said Friday it received the Ministry of Food and Drug Safety’s approval to sell its injectable treatment for submental fat, or double-chin.
Belkyra (ingredient: deoxycholic acid) is the first and only FDA-approved non-surgical injection for reduction of fullness under the chin, the company said.
Treatments for submental fullness have, until now, been limited to surgical options such as liposuction or weight-loss programs with limited improvement.
Belkyra is now an alternative to patients who are distressed by the fullness of the chin, according to Allergan. The medication permanently destroys fat cells, making it impossible for the cells to store or accumulate fat, the company said.
The safety and efficacy of the treatment were proven in two identical, randomized, multicenter, double-blind, and placebo-controlled clinical trials on 1,022 patients with moderate to severe extrusion or excessive chin fat.
The tests, maintained for around five years, showed that around 79 percent of the 514 patients in phase three clinical trials were satisfied with the treatment administered an average of two to three times a week.
“We are very pleased to be able to offer a new treatment option for the lower jaw that has been a major concern for many consumers with the MFDS approval,” said Allergan Korea CEO Kim Eun-young김은영. “As a leading company in the field of medical aesthetics, we will strive to provide effective treatment options for domestic patients and medical staff.”
Belkyra is licensed and marketed in 24 countries around the world, including the U.S., Canada, Australia, Iceland, and Hungary, having gained U.S. FDA approval in April 2015.
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