A new injection drug approved yesterday by the FDA offers the first non-surgical treatment for double chins—more accurately, moderate-to-severe “submental” fat below the chin.

Kythera Biopharmaceuticals won the agency’s go-ahead to market Kybella™ (deoxycholic acid, formerly ATX-101), a cytolytic drug that physically destroys the cell membrane when injected into fat tissue. The drug is indicated “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.”

“This milestone is a testament to our ability to translate science into first-in-class aesthetic products, and we look forward to applying our successful and efficient development model to future products,” Kythera CMO Frederick C. Beddingfield, III, M.D., Ph.D., said in a company statement.

Injected properly, Kybella is intended to destroy fat cells—though the FDA and Kythera warned that the drug can also destroy skin cells among other types of cells if injected into the skin. Kythera and the FDA have warned, however, that Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing.

To avoid the potential for nerve injury, Kythera said, Kybella should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.

Kythera developed a training program to teach physicians how to use Kybella safely. Physician education will begin in June, followed later this summer by physician training programs.

Doctors who complete the training program will be able to purchase Kybella and use it on patients. Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered no less than one month apart. Each in-office treatment session is typically 15–20 minutes, says Kythera, which adds that many patients experienced visible results in two to four treatments.

Kythera has yet to disclose the price of treatment via Kybella. Liposuction of submental fat costs between $2,700 and $5,175, the American Society for Dermatologic Surgery states on its website.

The FDA said it established the safety and efficacy of Kybella in two clinical trials assessing the drug on 1,022 adults with moderate or severe submental fat. Participants were randomly assigned to receive Kybella or a placebo for up to six treatments.

According to Kythera, 68.2% of patients responded to Kybella based on physician and patient measurements, with 82% of Kybella patients achieving a 1-grade improvement from baseline 12 weeks after the last treatment. Patients treated with Kybella not only reported an improvement in the amount of fat in the area under the chin—but improvement in the emotional impact of submental fat, based on being asked how happy, bothered, self-conscious, embarrassed, old, and overweight they felt following treatment.

The two trials were among more than 20 clinical studies with more than 2,600 patients worldwide in Kybella’s global clinical program—of which more than 1,600 patients were treated with the drug, Kythera said. The most common side effects of Kybella included swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area, the agency said.








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