NAPSRx News: FDA Approves KYBELLA- first and only submental contouring injectable drug

WASHINGTON - April 30, 2015 - PRLog -- On April 29, 2015, the U.S Food and Drug Administration (FDA) approved KYBELLA (deoxycholic acid) Injection manufactured by Kythera Biopharmaceuticals to improve Submental Fullness, or “Double Chin”. KYBELLA is the first and only non-surgical aesthetic treatment approved by the FDA to reduce submental fullness in individuals. It is administered by injections into the fat under the chin and each treatment session should last 15-20 minutes. According to the Kythera, patients saw visible results after two to four treatments. Once an aesthetic response is attained, no retreatment is expected. KYBELLA can be administered in up to six treatments.

“For the first time, people have access to an FDA-approved, non-surgical treatment for submental fullness, a condition that can negatively impact the overall appearance of the face and can result in a person feeling older and heavier,” said Keith Leonard, President and Chief Executive Officer of KYTHERA. “With KYBELLA™, physicians can offer a clinically-proven treatment that is customized to the patient and their treatment goals for an improved chin profile. Importantly, KYBELLA™ treatment resulted in high patient satisfaction.”

KYBELLA was assessed in over 1600 patients in a global clinical development program which comprised of 20 clinical studies. Based on the results of the fundamental Phase III studies, 68.2 percent of patients treated with KYBELLA responded to the treatment based on physician and patient measurements. Patients treated with KYBELLA reported significant improvement as the amount of fat in the area under chin was reduced. Overall, patients were tremendously satisfied with the treatment when asked how happy, bothered, self-conscious, embarrassed, old and overweight they felt following treatment. “A recent consumer survey by the American Society for Dermatologic Surgery revealed that 68 percent of consumers are bothered by fullness under their chin,” said George J. Hruza, M.D., President of the American Society for Dermatologic Surgery. “KYBELLA™ provides physicians with the first non-surgical treatment option to satisfy this unmet patient need.”

“We are pleased to bring this innovative product to market as it represents our commitment to meet the needs of physicians and their patients,” said Frederick C. Beddingfield, III, M.D., Ph.D., Chief Medical Officer, KYTHERA. “This milestone is a testament to our ability to translate science into first-in-class aesthetic products, and we look forward to applying our successful and efficient development model to future products.”

Kythera will conduct a training-led launch and also develop a training program to educate physicians on the safe use of KYBELLA™, and its approved indication.

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