Americans who are conscious with their "double chin" now have a reason to rejoice. On Wednesday, a drug that could help those with double chin has been green-lighted by the FDA.
The injectable drug dubbed Kybella contains deoxycholic acid, which the body produces and helps absorb fat. When it is injected into tissue, the drug destroys the cell membrane. The fat cells, however, get dissolved when it is injected into subcutaneous fat such as those that accumulate under the chin.
The drug is the first to be approved by the FDA to treat adults who have fat below their chin, also known as submental fat. Kythera Biopharmaceuticals, the company behind the newly-approved drug, described submental fat as a common aesthetic condition that is undertreated and which could lead to people feeling heavier and older.
The company plans to begin selling Kybella by the second half of this year. The drug will become available through plastic surgeons and dermatologists who are trained to properly administer the injectable.
The California-based company also said in regulatory filing that it believes the treatment could top $500 million in sales per year albeit the price of the treatments will not be announced until June when the physicians' training and marketing launch are scheduled to start.
Amy Egan, from FDA's Center for Drug Evaluation cautioned that treatment with Kybella must be provided by a licensed health care professional and that patients should be aware of the risks linked with the use of the drug before they should consider treatment.
The drug was not approved to be used outside of the area under the skin. It has not also been found safe for use in the buttocks and belly.
"It is important to remember that Kybella is only approved for the treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area," Egan said.
The newly approved product is expected to become available in late summer through dermatologists, plastic surgeons and facial plastic surgeons that have been trained in the proper administration of the injectable.
Derek Jones, who led Kybella's clinical trial, said that in the clinical trial, 79 percent of the subjects who received the drug reported that they were satisfied with their appearance. Some of the results were also found to be quite spectacular.
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