Health Canada approves Kythera's Belkyra for treating submental fat

Kythera Biopharmaceuticals announced that Health Canada has approved marketing of Belkyra for treating submental fat in adults.

Belkyra (deoxycholic acid) injection was recently approved by the FDA and launched in the United States under the brand name Kybella, according to the release. The Canadian approval was based on more than 20 clinical studies with more than 2,600 patients worldwide, including 1,600 patients who were treated with Belkyra, Kythera reported.

Vince Bertucci

In phase 3 studies, validated physician and patient measurements demonstrated that 68.2% of patients responded to Belkyra, according to the release.

“A broad range of my patients, both women and men of varying ages, complain of submental fullness because it makes them look older and heavier,” clinical investigator Vince Bertucci, MD, FRCPC, codirector of the Dermatologic Laser Surgery and Cosmetic Dermatology Fellowship at the University of Toronto, consulting dermatologist at Women’s College Hospital and president of the Canadian Dermatology Association, said in the release. “Belkyra will provide my patients with a nonsurgical solution that can be tailored to their individual treatment goals for an improved chin profile.”

Swelling, bruising, pain, numbness, redness, tingling or itchiness, a sensation of warmth or hardness in the treatment area were commonly reported adverse events in the clinical trials, according to the release.

Reference: www.kythera.com