The Food and Drug Administration has approved a new treatment “for adults with moderate-to-severe fat below the chin,” the agency announced on Wednesday.
The treatment is an injection — with up to 50 injections given in each treatment session — that’s made by Kythera Pharmaceuticals. Called “Kybella,” it’s a copy of a substance the body produces to break down fat by destroying cell membranes.
If not used correctly, it can destroy other cells in its path, including skin cells.
In two clinical trials that included more than 1,000 people, side effects of Kybella included bruising, pain, and numbness. More severe, less common side effects were nerve injuries in the jaw and trouble swallowing.
“Patients should fully understand the risks associated with use of the drug before considering treatment,” said Amy G. Egan, M.D., M.P.H. of the FDA in a statement. “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.”
According to an analyst cited in a FierceBiotech report, Kybella could eventually bring in $US300 million a year.
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