This article is more than 5 years old. Information may no longer be current.
FDA approves ATX-101 for treatment of submental fat
The FDA announced today it has approved Kybella, also known as ATX-101, for the treatment of moderate-to-severe submental fat in adults.
Kybella (deoxycholic acid, Kythera Biopharmaceuticals) is not approved nor recommended for treating fat outside the submental area, according to an FDA press release.
“Treatment with Kybella should only be provided by a licensed health care professional, and patients should fully understand the risks associated with the use of the drug before considering treatment,” Amy G. Egan, MD, MPH, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said in the release. “It is important to remember that Kybella is only approved for treatment of fat occurring below the chin, and it is not known if Kybella is safe or effective for treatment outside of this area.”
ATX-101 is a cytolic drug, which physically destroys the cell membrane when injected into tissue, according to the release. The drug destroys fat cells when properly injected into submental fat; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin.
Patients may receive up to 50 injections in a single treatment, with up to six single treatments administered less than 1 month apart, the FDA release stated. Results of two clinical trials including 1,022 adult participants with moderate-to-severe submental fat were used to establish the safety and effectiveness of the treatment.
Side effects include nerve injury to the jaw that can cause an uneven smile or facial muscle weakness, as well as trouble swallowing, according to the release. Common side effects include swelling, bruising, pain, numbness, redness and areas of hardness in the treatment areas.
An FDA advisory committee recommended ATX-101 approval in March.
References: www.fda.gov, www.kythera.com.
Perspective
Back to Top
As a cosmetic dermatologist, I am very enthusiastic about the FDA approval of Kybella, specifically because it fills an unmet need in my practice.
Until now, the most specific and targeted correction for submental fullness would be a surgical correction, and many cosmetic dermatologists don’t offer those procedures. Furthermore, many patients in today’s society are unwilling to consider surgical corrections. We’ve seen a huge increase in minimally invasive procedures with little or no downtime, and that trend continues to build.
This is why Kybella comes at such a relevant time. We now have a treatment option for a common presenting complaint. In cosmetic dermatology, until this point, submental fullness went largely untreated. We could relax the platysma with neuromodulators and we could tighten the skin with noninvasive skin tightening procedures, but none of these procedures targeted the problem of submental fullness.
Submental fullness is not necessarily related to weight control, so oftentimes healthy patients with normal body weights have a genetically predetermined pocket of submental fat, and Kybella will really expand our therapeutic armamentarium.
Finally, a well-defined jawline and cervicomental angle are features that are aesthetically pleasing and associated with a youthful and healthy appearance.
Perspective
Back to Top
Kybella is a first-in-kind injectable that reduces submental chin fullness (or double chin).
The side effects that my test subjects experienced were stinging, burning at injection and swelling and some mild discomfort for several days post-injection. The amount of discomfort varies from minimal to moderate in severity. Ice packs seem to help prevent/abate this adverse event.
Patients typically required monthly injections for 2-3 sessions to achieve optimal results. Although the mechanism was unclear (inflammation perhaps?), skin tightening was visible in most patients.
I see this as an important tool for the non-surgical dermatologist to offer aesthetic improvement of the chin and jaw line. It will complement neurotoxin injections into the platysma and fillers into the lower face and ultrasound and radiofrequency devices, to achieve a facelift-like improvement to the contours of the lower face.
Perspective
Back to Top
The approval of Kybella by the U.S. FDA is the start of an exciting new therapeutic modality. To be able to remove submental fat with only an injection is a dramatic advance. The Kybella phase 3 study results are compelling, demonstrating both safety and efficacy.
Those of a negative turn of mind will point to the discomfort the patients experience during treatment as well as the swelling and bruising reported in the study. However, the benefit of the procedure will outweigh the adverse events and physicians in the cosmetic world are well aware of the tolerance of our patients for minor adverse events if the result is worth it! This new treatment will be of especial interest to those who have already had submental liposuction but still have residual fat as well as males who are reluctant to undergo a procedure which might leave them with obvious scars or other evidence of a cosmetic procedure.
The FDA approval releases Kybella for the use of American physicians. It will also allow the American physicians to perfect the Kybella procedure.
This is an exciting new era in cosmetic therapy!
Perspective
Back to Top
Kybella's approval for the treatment of submental fat (double chin) marks a milestone for aesthetic patient choice. With the addition of an approved injectable treatment for this troublesome condition, patients now have a viable alternative to surgical reduction of anterior cervical and horizontal submental fat deposits.
While open lipectomy and tumescent liposuction are well-established safe and effective methods of fat reduction and removal, not all patients are appropriate candidates for surgery.
Now patients have an additional option to consider. Combined with complementary procedures for neck rejuvenation such as micro focused ultrasound (MFUS), neurotoxin, and skin resurfacing, the aesthetic patient has the potential to achieve a full non-surgical total neck rejuvenation.
As a principal investigator for the phase 3 clinical trials leading to the FDA approval, I have experienced firsthand the potential for dramatic improvement with the use of Kybella. Never before was there a way to non-surgically approach treatment of this troublesome area. I applaud Kythera for having the determination to proceed with the clinical trials necessary to bring this transformative product to market.
Perspective
Back to Top
Until now, there has been no FDA approved injectable drug to contour submental fullness, or “double chin.” While surgical procedures yield positive outcomes in the treatment of submental fullness, many patients prefer non-surgical methods. This is a huge advancement in the aesthetic industry, especially for patients who are looking for a non-surgical treatment option.
As a principle investigator during the Phase 3 study of Kybella, I heard that overall, patients were highly satisfied following treatment with Kybella. Because the fat cells are destroyed, once the aesthetic response is achieved, re-treatment is not expected. As with any injectable drug, I want to stress the importance of seeing a properly trained board-certified physician such as a plastic surgeon, facial plastic surgeon or dermatologist.