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KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today that the U.S. Food and Drug Administration (FDA) has approved KYBELLA™, also known as ATX-101, “for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.” KYBELLA™Â is the first and only approved non-surgical treatment for reduction of submental fullness, a common yet under-treated aesthetic condition.

KYBELLA™Â is supported by a global clinical development program that includes over 20 clinical studies with more than 2,600 patients worldwide, of which over 1,600 have been treated with KYBELLA™. In the pivotal Phase III studies, 68.2 percent of patients responded to KYBELLA™Â based on a composite of validated physician and patient measurements.ⁱⁱ Patients treated with KYBELLA™Â reported an improvement in the amount of fat in the area under the chin. Patients 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.

The most common adverse reactions were associated with the injection site and included swelling, bruising, pain, numbness, erythema and formation of small areas of firmness around the treatment area. The percentage of adverse reactions reported as mild were 81 percent, moderate 17.4 percent, and severe 1.6 percent.

KYBELLA™Â is administered by injections into the fat under the chin, tailored to the treatment goals of the patient and the physician. Each in-office treatment session is typically 15-20 minutes. Many patients experienced visible results in two to four treatments.  Up to six treatments may be administered. Once the aesthetic response is achieved, retreatment is not expected.

KYTHERA has chosen to execute a training-led launch and developed a training program to educate physicians on the safe use of KYBELLA™, and its approved indication. Physician faculty education will begin in June 2015. KYBELLA™Â physician training programs will initiate in late summer. Physicians will be able to purchase KYBELLA™Â and treat their patients after they have been trained.

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