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Kybella (deoxycholic acid) (Canadian trade name: Belkyra)


Company:     Kythera Biopharma

Approval Status:     Approved April 2015

Specific Treatments:     submental fat

Therapeutic Areas     Dermatology     Family Medicine

General Information

Kybella (deoxycholic acid) (Belkyra) is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, Kybella causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. The preference for fat cells leaves surrounding tissue largely unaffected.

Kybella is specifically indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

Kybella is supplied as an injection for subcutaneous administration. Kybella is injected using an area-adjusted dose of 2 mg/cm2. A single treatment consists of up to a maximum of 50 injections, 0.2 mL each (up to a total of 10 mL), spaced 1-cm apart. Up to 6 single treatments may be administered at intervals no less than 1 month apart.

Clinical Results

FDA Approval

The FDA approval of Kybella was based on two identical randomized, multi-center, double-blind, placebo-controlled trials in healthy adults (ages 19 to 65, BMI ≤ 40 kg/m2 ) with moderate or severe convexity or fullness associated with submental fat. Subjects received up to 6 treatments with Kybella (N=514, combined trials) or placebo (N=508, combined trials) at no less than 1 month intervals. Use of ice/cold packs, topical and/or injectable local anesthesia was allowed during the clinical trials. Injection volume was 0.2 mL per injection site, spaced 1 cm apart into the submental fat tissue, which is also expressed in dose per area as 2 mg/cm2 . For each treatment session a maximum of 100 mg (10 mL) was permitted over the entire treatment area. Subjects were administered an average of 6.4 mL at the first treatment session, and subjects who received all six treatments were administered an average of 4.4 mL at the sixth treatment session. Fifty-nine percent of subjects received all six treatments. The co-primary efficacy assessments were based on at least 2-grade and at least 1-grade improvements in submental convexity or fullness on the composite of clinician-reported and patient-reported ratings of submental fat 12 weeks after final treatment. Reductions in submental fat volume were observed more frequently in the Kybella group compared to the placebo group. 68.2% of subjects responded to Kybella based on a composite of validated physician and patient measurements. Subjects treated with Kybella reported an improvement in the amount of fat in the area under the chin. Subjects also reported improvement in the emotional impact of submental fat when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment in relation to the amount of their submental fat.

Side Effects

Adverse effects associated with the use of Kybella/Belkyra may include, but are not limited to, the following:

injection site edema/swelling
hematoma
pain
numbness
erythema
induration

Mechanism of Action

Kybella (deoxycholic acid) (Belkyra)  is a non-human and non-animal formulation of deoxycholic acid, a naturally-occurring molecule in the body that aids in the breakdown and absorption of dietary fat. When injected into subcutaneous fat, Kybella causes the destruction of fat cells. Once destroyed, those cells cannot store or accumulate fat. The preference for fat cells leaves surrounding tissue largely unaffected.

Additional Information

For additional information regarding Kybella or submental fat, please visit http://mykybella.com/

作用機制

KYBELLA/Belkyra是合成的脫氧膽酸(deoxycholic acid)，藉破壞細胞膜來破壞脂肪細胞， 有助人體吸收脂肪，以減少脂肪積聚，達致消除雙下巴。

注射部位

美國食品及藥物管理局（FDA）認可KYBELLA / BELKYRA 可以有效減少雙下巴脂肪