Mark A. Bishara, MD

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Double Chin? There May Be a Drug for That

By http://www.markbisharamd.com/author/
January 28, 2015

A recent article in Bloomberg Business discusses how people who suffer from an unsightly double chin may not need to contort their head, neck and face into funny positions to try to work off the extra roll if U.S. regulators sign off on a new drug.

Kythera Biopharmaceuticals Inc.’s experimental drug is injected into fat under the chin. The drug is a version of deoxycholic acid, a molecule that occurs naturally in the body to help destroy fat.

Kythera Biopharmaceuticals Inc. aims to bring true, rigorous clinical science to cosmetic dermatology with prescription drugs that modulate novel biological pathways in aesthetic and restorative indications.

The injection is still not approved by the U.S. Food and Drug Administration. A panel of outside advisors and academics will discuss whether the FDA should approve the first-of-its-kind treatment on March 9. The agency doesn’t have to follow the panel’s recommendation.

Kythera, based in Westlake Village, California, says the drug, ATX-101, contours the chin without affecting surrounding tissue. Injectable drugs like Allergan Inc.’s Botox and dermal fillers aren’t approved to fix fat and loose skin under the chin, making ATX-101 potentially the first injection for the area to hit the market if approved.

ATX-101, is an adipolytic agent discovered at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA Biomed) and identified by Munshi. Adipolytic therapy, dissolving fat by injection, has been used for several decades, primarily outside of the US, but the products used are unregulated; thus there has been no real understanding of their mechanism of action.

Chin augmentations were the fastest-growing category of plastic surgery in the U.S. in 2011, according to an analysis by the American Society of Plastic Surgeons. There were 20,680 chin procedures in 2011, and they grew more than breast augmentation, Botox and liposuction treatments combined, according to the society.

The FDA is scheduled to rule on the drug by May 13. It would be Kythera’s first product for sale, and could generate $505 million in sales in 2020, according to data compiled by Bloomberg.

The drug has been tested on 1,600 patients in clinical trials, more than 90 percent of whom maintained a meaningful reduction of fat after two years, Kythera said on its website.

 

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