Los Angeles Times

FDA approves drug to reduce double-chin fat

- By Stuart Pfeifer stuart.pfeifer@latimes.com

The Food and Drug Administra­tion has approved a Westlake Village company’s injectable drug as a treatment to reduce double-chin fat in adults.

Kythera Biopharmac­euticals Inc. said in a news release that injections of the drug have been shown in clinical studies to be both safe and effective in reducing fat under the chin.

It will sell the drug under the brand name Kybella. The company plans to launch the drug this summer through physicians who complete a training program.

“For the first time, people have access to an FDA-approved, non-surgical treatment” for double chins, said Keith Leonard, chief executive of Kythera.

In an interview with The Times in 2013, Leonard said he thought the drug could eventually generate more than $500 million in annual sales.

“We really think we’re going to be the next big thing in aesthetics,” he said.

Kythera’s stock fell $2.05, or 4.3%, to $45.59. The FDA approval had been widely expected.

Kybella will be administer­ed during in-office doctor visits that typically last 15 to 20 minutes. Many patients saw visible results after two to four visits, the company said, but up to six treatments may be administer­ed.

In addition to physical benefits, patients in the clinical trials reported being less self-conscious, Kythera said. Fat under the chin can affect men and women, regardless of age or weight.

“I see many patients who have undesirabl­e fullness under the chin, even though they may have an otherwise balanced and harmonious facial appearance and be in great physical shape,” said Dr. Derek H. Jones, a UCLA dermatolog­y professor and lead investigat­or in clinical studies of the drug.

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