SILVER SPRING, MD – A less-invasive alternative to liposuction and other cosmetic treatments for submental fat will likely become available in the United States in the wake of a Food and Drug Administration advisory panel’s unanimous support for approval of deoxycholic acid as an injection into subcutaneous fat under the chin.
At a meeting on March 9, the FDA’s dermatologic and ophthalmic drugs advisory committee voted 17-0 that the efficacy and safety data on 1% deoxycholic acid (DCA) injection supported approval for the proposed indication, “the improvement in the appearance of moderate to severe convexity or fullness associated with submental fat” in adults.
The product is a synthetic version of naturally occurring DCA, an endogenous secondary bile acid that “serves to emulsify and solubilize dietary fat,” and for cosmetic use, “disrupts cell membranes of adipocytes, causing destruction of fat cells,” according to the manufacturer, Kythera Biopharmaceuticals.
The regimen proposed by Kythera is up to six treatment sessions with 4-week intervals between sessions. Each session would involve up to 50 injections, with 0.2 mL of DCA solution per injection, administered subcutaneously using a grid to control spacing of injections. The product would be the first drug approved for treatment of submental fat.
A pair of phase III studies including about 1,000 adults (median age, 48-49 years) randomized patients to treatment with DCA or placebo saline injections of 6 or fewer treatments, one month apart. The effects were evaluated with validated Clinician-Reported and a Patient-Reported Submental Fat Rating Scales (CR-SMFRS and PR-SMFRS), which Kythera developed in consultation with the FDA. On the CR-SMFRS, a 5-point rating scale ranged from 0 (no localized submental fat evident) to 4 (extreme submental convexity).
Most patients enrolled were rated as 2 (moderate, with prominent localized submental fat) or 3 (severe, with marked localized submental fat); the company is not seeking an indication for extreme submental convexity. On the PR-SMFRS, patients had five options to check off, based on how much fat they thought they had under their chin when looking in a mirror, ranging from “no chin fat at all” to a “very large amount of fat.”
The coprimary efficacy endpoints were those who had at least a 2-grade improvement on both scales, or at least a 1-grade improvement in both scales, 12 weeks after the first treatment.
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