FDA staff backs injection to reduce double chin
According to an article in Reuters An injection for “double chin” reduction developed by Kythera Biopharmaceuticals Inc cleared the first hurdle toward approval as U.S. Food and Drug Administration staff concluded the drug’s benefits outweighed its risks. www.fda.gov
Kythera’s stock jumped as much as 25 percent as investors bet on what could be the first approved drug in the United States to reduce localized fat deposits. The drug, ATX-101, is a formulation of deoxycholic acid, which destroys fat cells under the chin but leaves surrounding tissue largely unaffected. Existing options are limited to surgeries performed under general anesthesia and liposuction.
No safety issues associated with long-term use of ATX-101 have been identified so far, FDA reviewers commented. An independent panel of experts will meet to discuss the drug and recommend to the FDA whether it should be approved. The FDA typically accepts the panel’s recommendations.
Leerink Partners analyst Seamus Fernandez said he expects the drug to be approved by May 13, when the FDA is scheduled to make its final decision. Last year, Kythera regained rights to the market the drug outside the United States and Canada from a unit of Germany’s Bayer AG.
The potential new injectable created a lot of buzz at the 2014 Annual Meeting of the American Society for Dermatologic Surgery. “If approved for use, this medication will create a new market in terms of how we think about fat and facial aesthetics,” says Adam M. Rotunda, M.D., FACMS, a diplomat with the American Board of Dermatology in an interview with Dermatology Times. “As dermatologists, we’ve been accustomed to addressing patient aesthetic concerns primarily from the chin up. However, the neck or submental region is critical in framing the lower half of the face and creating our profile. Changes in the neck as we age or gain weight can have profound effects on our self-esteem or self-perception,” Via ATX-101, he says, “we would be able to offer patients an injectable-minimally invasive-non-surgical treatment to reduce small pockets of fat. Furthermore, improving the appearance of the neck with ATX-101 has been shown in Kythera’s clinical trials to make patients happier, less embarrassed, younger and less overweight.”
In the big picture, Dr. Rotunda says, “many of my colleagues and I are very excited about this potential new treatment. We’ve all been waiting for something new in an injectable that is not a toxin or filler.” www.dermatologytimes.modernmedicine.com
If you are seeking more information on facial and body plastic surgery you should make an appointment with a board certified plastic surgeon like Dr Aguiar. At Aguiar Plastic Surgery, we offer state-of-the art, safe, and effective cosmetic procedures, plastic surgery, reconstructive surgery, and Med Spa services in Tampa, Florida. We can discuss your concerns and give you an honest consultation that is designed and tailored to create an appearance on the outside that will reflect how you feel on the inside.
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