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news.Kythera Biopharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Kybella (ATX-101) to treat adults with moderate-to-severe fat below the chin, also known as submental fat.
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Kybella is a cytolytic drug, which when injected into the fat under the chin destroys the cell membrane.
When injected into submental fat, the drug works by destroying fat cells, while it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
Kythera president and chief executive officer Keith Leonard said: "For the first time, people have access to an FDA-approved, non-surgical treatment for submental fullness, a condition that can negatively impact the overall appearance of the face and can result in a person feeling older and heavier.
"With Kybella, physicians can offer a clinically-proven treatment that is customized to the patient and their treatment goals for an improved chin profile. Importantly, Kybella treatment resulted in high patient satisfaction."
Kybella is supported by a global clinical development program that includes over 20 clinical trials with over 2,600 patients across the world, of which over 1,600 have been treated with the drug.
The company said that in the pivotal Phase III trials, 68.2% of patients responded to Kybella based on a composite of validated physician and patient measurements.