UPDATE: FDA APPROVED 4/29/2015, Now known as “Kybella”
UPDATE: KYTH Bought out by Allergan. Price of stock at time of original blog: 41.95, buyout price over 75
Kythera announced yesterday (9/16/2013) that they had 2 phase 3 studies for fat reduction in the submental area (underneath the chin) or “double chin” with just injections with their product ATX-101. The results were very positive, with 70% having one grade of change and 13.4% having 2 grades or more change. No serious side effects were noted. Minor side effects were discomfort and swelling which resolved. Another interesting positive outcome were the patient’s subjective scores on “happiness, self consciousness, feeling old, overweight, embarrassment, and being bothered” were all improved to the positive, several fold over the placebo. The results were sustainable as well with 90% still improved at 2 years and 80% sustaining benefits after 3 and 4 years.
Why is this a big deal? We can now destroy fat noninvasively with just injections. Granted, ATX-101 will probably only be useful for small areas of fat but it opens the door for off label use in areas other than the chin. Mesotherapy, multiple small injections to dissolve fat deposits, which has been done with non FDA approved products in the past, can now be somewhat legitimized with using FDA approved ATX-101, when and if it is approved. I suspect that ATX-101 will be approved in 2014 and late 2014 it will be in the hands of all the cosmetic physicians in the country. Soon there will be courses and experts, using the product all over the body for contouring. Heck, to have injections instead of liposuction, its a no brainer.
Another possible off label use for ATX-101 is for lipomas, benign fatty tumors, usually fairly superficial and slow growing. For those not wanting to have surgery and the scar that would follow, lipomas could be controlled with injections of ATX-101. Some people have multiple lipomas and the thought of having scars all over their body is not as attractive as getting injections to keep them “at bay” or make smaller.
There will still be a place for liposuction and Coolsculpting because the larger areas of fatty deposits won’t be treatable with ATX-101.
Looking for a good investment, buy KYTH. I suspect that this is quickly bought up by either Allergan (AGN) or Valeant (VRX) who both have cosmetic injectables (Botox, Restylane, Juvederm, Sculptra, Dysport) that would love to add this to their product lines.
The Aesthetic Clinique, and Dr. Steve Weiner, MD, Facial Plastic Surgeon, will be one of the first to have Kythera’s ATX-101 when it is FDA approved in 2014. For more information about Dr. Weiner and The Aesthetic Clinique, see http://www.theclinique.net
KYTH study results: http://www.kytherabiopharma.com/newsroom/
Dr. Steven Weiner is a Board Certified Facial Plastic Surgeon practicing in Santa Rosa Beach, Florida, between Destin and Panama City Beach, Florida. After laying down his scalpel in 2005 he has devoted his practice to Lasers and Injectables.