The Food and Drugs Administration (FDA) has approved Kybella as a treatment for moderate to severe submental fat.
According to the FDA, the drug, manufactured by Kythera Biopharmaceuticals, is identical to the deoxycholic acid that is produced in the body, which works to help the body absorb fats.
The safety and effectiveness of Kybella, also known as ATX-101, was established following two clinical trials that enrolled 1,022 adult participants with moderate or severe fat below the chin.
Participants underwent treatment with either Kybella or a placebo for up to six treatments, and results indicated that reductions in submental fat were observed more frequently in those who received Kybella.
The FDA explained that Kybella is a cytolytic drug, which aims to destroy fat cells when injected into submental fat. It also warned that the drug could further destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
Serious side effects include nerve injury in the jaw, which could cause an uneven smile, facial muscle weakness or trouble swallowing, according to the FDA. Other common side effects include swelling, bruising, pain, numbness, redness and hardness in the treatment area.
Dr Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Centre for Drug Evaluation, said, “It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
The FDA added that Kybella should not be used if there is an infection at the injection site, and emphasise that caution should be taken in patients who have had prior surgical or non-surgical aesthetic treatment of the submental area.