New FDA chin drug

New FDA chin drug

Those who have dreamed of getting rid of a double chin but dreaded the idea of going under the knife now have a new option. The U.S. Food and Drug Administration recently approved Kybella as a treatment for adults with moderate to severe chin fat. Kybella, manufactured by Westlake Village, Calif.-based Kythera Biopharmaceuticals Inc. contains

Those who have dreamed of getting rid of a double chin but dreaded the idea of going under the knife now have a new option.

The U.S. Food and Drug Administration recently approved Kybella as a treatment for adults with moderate to severe chin fat. Kybella, manufactured by Westlake Village, Calif.-based Kythera Biopharmaceuticals Inc. contains deoxycholic acid, which is what the body uses to absorb fat. When injected into fat under the chin Kybella permanently destroys the fat cells, according to the FDA.

Kybella is the first drug to obtain approval in the U.S. to treat double chin fat.

The beauty industry is big business in the United States, with nearly 16 million cosmetic procedures taking place in 2014, according to the American Society of Plastic Surgeons. Consumers spent $12.9 billion on cosmetic procedures last year, up 2 percent from 2013.

Indeed, the market for non-invasive cosmetic procedures is vast. In 2014 13 million minimally invasive cosmetic procedures were performed, versus 1.6 million cosmetic surgical procedures, according to the American Society of Plastic Surgeons. There has been a 154 percent increase in non-surgical cosmetic treatments since 2000, Financial Times previously reported, and the number is only expected to increase, as injectables like Kybella appeal to patients who want to avoid both the cost and recovery time of surgery.

Until now surgery was the only option available for patients who wanted to remove fat from under their chin. Liposuction typically costs about $3,000, according to the American Society of Plastic Surgeons, and patients must go under general anesthesia for the surgery. Liposuction is among the top five cosmetic procedures in the U.S., according the organization.

Kybella is now an alternative to invasive surgery. However, Kybella’s results are not instantaneous. Patients may receive up to 50 injections during one treatment, and with multiple treatments doled out during a six-month span.

Still, Kybella can cause serious side effects including nerve injury in the jaw, swelling, bruising, pain, numbness, redness and hard areas in the treated skin, according to the FDA. If injected into the skin by mistake, Kybella may destroy skin cells. The drug has been approved only for use on chin fat.

Houston-area board certified plastic surgeon Dr. Daniel Casso said he commonly performs liposuction under the chin in his patients and understands the appeal of the drug.

“Kybella may be attractive to patients who prefer minimally invasive treatments, although the reality is that risks and complications associated with submental liposuction are fairly minimal,” said Dr. Casso, whose office is located on Nasa Parkway across the street from the Johnson Space Center. “In fact, risks associated with Kybella treatment as noted in product inserts closely mirror risks of liposuction.

In addition, one liposuction procedure under local anesthesia can be performed on average between $2,000 and $3,000, he said.

“Patients should be aware that with any medical procedure or treatment, best results can be expected when treatment is provided by physicians with broad training and experience,” Casso said. “Patients should also consider whether the costs, discomfort, inconvenience, time off of work, etc. of multiple (2 to 6) treatments with Kybella outweigh the corresponding inconveniences of liposuction.”

Casso said he prefers to be cautious and avoid new treatment modalities until long-term results can be assessed. Meanwhile, liposuction is generally well tolerated and “excellent correction” can be achieved in just one session, he said.

“Patients who see me are typically generally aware of the nature of submental liposuction surgery and are comfortable with the process,” Casso said. “I do explain the procedure in detail, including the recovery process, and show patients before and after photos of my patients so that they can anticipate their results. There may be some patients in the future who prefer a more incremental process of fat removal, and if long-term results of this technique prove favorable, I may consider this procedure for them.”

The drug will cost physicians $300 per vial. Patients will need an average of two to three vials a session, the Wall Street Journal previously reported.

The drug may be new, but it is already making headlines. Physicians who have undergone training through Kythera Biopharmaceuticals have already begun offering the treatment, the New York Post reports. Doctors have likened the demand of Kybella to Botox, which may explain another company’s interest in the drug.

In June Kythera agreed to be acquired for $2.1 billion by the maker of Botox, Dublin, Ireland-based Allergan Inc., the Wall Street Journal reported. Botox was the top minimally invasive cosmetic procedure in 2014, with 6.7 million injections delivered during the year, according to the American Society of Plastic Surgeons. Kybella may soon join Botox on that list.

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