The sponsor conducted two pivotal phase three trials in the U.S. and Canada, involving 1,022 patients.
On Monday, the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously (17-0) in favor of approval of deoxycholic acid (DCA) subcutaneous injection (Kythera Biopharmaceuticals) for the improvement of the appearance of moderate-to-severe convexity or fullness associated with submental fat. DCA destroys fat cell membranes at the injection site.
The sponsor conducted two pivotal phase three trials in the U.S. and Canada, involving 1,022 patients. The trials were identical in design, and each treatment arm was roughly even in size. Participants received injections “spaced on a 1 cm grid” every 4 weeks, with a maximum of six sessions and no more than 50 injections total, briefing documents noted.
Results in the two trials showed that deoxycholic acid injections were superior to placebo for both the primary (evaluation of the amount of submental fat) and secondary endpoints (magnetic resonance imaging (MRI) scans of the chin and neck and Patient-Reported Submental Fat Impact Scale). Two-grade improvements were seen in 13.4% and 18.6% of participants receiving the active drug in the two studies, versus 0.1% and 3% of those in the placebo groups. Another 70% and 66.5% of subjects showed one-grade improvements, compared with 18.6% and 22.2% in the placebo groups.
Common side effects included bruising, swelling and pain.The MRI scans showed 46% and 40.5% improvement in active-treatment groups compared with 5.2% and 5.3% improvements with placebo.
Despite the positive results, some committee members said they were concerned about the potential for adverse events related to off-label uses of the drug in different locations and amounts.
Robert “Bob” Murphy, Jr., MD, plastic surgeon Lehigh Valley Health Network in Bethlehem, Pa., said he felt the research was “nicely presented and controlled” but worried that some clinicians might use it in the periorbital area where its effects aren’t known.
Chairperson of DODAC, Lynn A. Drake, MD, added that, “if used properly, with appropriate training and appropriate precautions, I think [this product] it’s helpful.”
If it wins final FDA approval, deoxycholic acid will be the first medical treatment for excess chin fat.
The FDA is not obligated to follow the advice of its advisory committee panels, but normally does so.
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