Kythera Grabs FDA Approval for Chin Fat-Busting Drug

Kythera Grabs FDA Approval for Chin Fat-Busting Drug
April 30, 2015
By Alex Keown, BioSpace.com Breaking News Staff

WESTLAKE VILLAGE, Calif. – People with a “turkey neck,” or double chin, that pocket of embarrassing fat under their chins, now have a new non-surgical option with the U.S. Food and Drug Administration (FDA)’s approval of Kybella, a pharmaceutical treatment for “submental fullness” manufactured by Kythera Biopharmaceuticals, Inc. .

Kythera’s stock saw a big jump in early morning trading, going as high as $51.81 per share, but those gains have since trimmed back closer to Wednesday’s close of $45.59 per share as trading continued.

During Phase III clinical trials, 68.2 percent of reported an improvement in the amount of fat in the area under the chin after undergoing the injectable treatment, the company said. Not only did the medication reduce the amount of fat pockets underneath a patient’s chin, the company said many patients also reported an emotional improvement due to the loss of something many consider embarrassing. Kybella is a formulation of synthetically-derived deoxycholic acid, which destroys fat under the chin, leaving surrounding tissue largely unaffected. Kybella is different from other facial injectables such as Allergan Inc. ’s Botox, which smoothes out wrinkles in skin.

“This milestone is a testament to our ability to translate science into first-in-class aesthetic products, and we look forward to applying our successful and efficient development model to future products,” Frederick C. Beddingfield, Kythera’s chief medical officer, said in a statment

Kybella is administered by injections into the fat under the chin, tailored to the treatment goals of the patient and the physician. Each in-office treatment session is typically 15-20 minutes. Many patients experienced visible results in two to four treatments. Up to six treatments may be administered. Once the aesthetic response is achieved, retreatment is not expected, the company said.

Before the drug is sold to physicians, Kythera said it will conduct a training program to teach physicians how to safely administer the drug. Training programs are expected to begin sometime in June and the drug will be available for sale after the training program, the company said. A pricing plan was not announced.

According to 2014 statistics released by the American Society for Aesthetic Plastic Surgery, Americans spend more than $12 billion on both surgical and non-surgical procedures annually. Turkey neck is a difficult to remove pocket of fat for even the most physically fit of individuals. George J. Hruza, president of the American Society for Dermatologic Surgery, said a consumer survey conducted by the ASDS revealed 68 percent of consumers are bothered by fullness under their chin.

“Kybella provides physicians with the first non-surgical treatment option to satisfy this unmet patient need,” he said.

Typical surgical treatments involve liposuction, which costs between $2,700 and $5,175, Reuters reported this morning.

Last year, Kythera regained the rights to market the drug outside the United States and Canada from a unit of Germany's Bayer AG , Reuters said.

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