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FDA’s approval of Kybella (deoxycholic acid), a less-invasive, non-surgical option for adults with moderate-to-severe fat below the chin, known as submental fat, or double chin, bodes well for the future of Kythera Biopharmaceuticals.
FDA’s approval of Kybella (deoxycholic acid), a less-invasive, nonsurgical option for adults with moderate-to-severe fat below the chin, known as submental fat, or double chin, bodes well for the future of Kythera Biopharmaceuticals, according to an industry insider.
Santilli“The new product will fill a growing need by a large population of Americans who wish to maintain a youthful appearance and in their own way delay signs of aging,” said John Santilli partner, Access Market Intelligence, in Trumbull, Conn.
“Nonsurgical procedures growth is exploding in the US aesthetics market and this product should be able to grow with the market,” he said.
Related: FDA drug approvals
Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin, according to an FDA press release.
Using Kybella for the treatment of fat outside of the submental area is not approved and not recommended. It should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.
Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to 6 single treatments administered no less than 1 month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.
Two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat established the safety and effectiveness of Kybella for this indication. Participants were randomly assigned to receive Kybella or a placebo for up to 6 treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.
Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. Swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area were the most common side effects of Kybella.
Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.