Therapeutic for double chins

KYTHERA Biopharmaceuticals announces FDA acceptance of ATX-101 New Drug Application

Lloyd Dunlap
CALABASAS, Calif.—KYTHERA Biopharmaceuticals, Inc. has announced that its New Drug Application (NDA) for ATX-101 (deoxycholic acid), has been accepted for filing by the U.S. Food and Drug Administration (FDA) for the treatment of double chins. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. The PDUFA date is the goal date for the FDA to complete its review of the NDA.

In addition, the FDA has informed the company that the FDA's Division of Dermatology and Dental Products is currently planning to hold an Advisory Committee meeting on the ATX-101 application during the review.
 
In August last year, the company’s stock shot up almost 25 percent after it released some new results from clinical trials it expected to form the basis of its application for FDA approval. The results impressed analysts following the company: “We see a very high probability of a 2015 approval for ATX-101 in the U.S. and Europe,” wrote J.P. Morgan, calling the new data “better than expected,” and leading the analyst to predict a annual market of up to $500 million.
Dealing with double chins—referred to as submental fat—could be big business. Here’s how Kythera’s CEO, Keith Leonard, explained the opportunity in an earnings call back in August: “The submental region is visually important and impacts overall facial harmony and balance,” he stated. “Research indicates a suboptimal chin profile resulting from excess submental fat is a hallmark of aging of the lower face and neck and can lead to negative self image. Further, an excess of submental fat may be coincident with other aging processes such as sagging and lipoatrophy of the lower face, and can also have dietary causes, or result from a genetic predisposition. Regardless of the cause, excessive submental fat and the resulting unsatisfactory submental profile can result in low self-esteem and dissatisfaction.”
 
“Despite being visually and psychologically important, the submental region is often overlooked and undertreated,” Leonard added. “In fact, there are no current FDA-approved injectable drugs for the reduction of submental fat. While liposuction or lower face and neck lift can be effective for removing excess submental fat, we know that not everyone wants or is a candidate for surgery.”
 
KYTHERA submitted the ATX-101 NDA to the FDA on May 12, 2014. The NDA submission was based on the positive results of two Phase 3 trials, which were reported late last year and showed that the majority of participants saw a visible reduction in submental fat and significant improvement in the visual and emotional impact of treatment. KYTHERA intends to make multiple ex-U.S. regulatory submissions by Q2 2015. The company acquired all rights to ATX-101 outside of the United States and Canada from Bayer Consumer Care AG in March 2014, to which it had licensed commercial rights for the compound outside of the United States and Canada in 2010.

"We are pleased that KYTHERA's NDA filing has been accepted by the FDA, representing another significant corporate milestone," said Leonard. "While the area under the chin is important to patients, there are no proven non-surgical options to effectively contour the area under the chin. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat."

ATX-101 is a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat.* ATX-101 treatment contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected.

For the past seven years, ATX-101 has been the focus of a global clinical development program that has enrolled more than 2,500 patients worldwide, of which more than 1,500 have been treated with ATX-101. ATX-101 has the potential to be a first-in-class submental contouring injectable drug if approved.

KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.

*Stryer L. Biosynthesis of membrane lipids and steroids. In: Biochemistry. New York, NY: WH Freeman and Co; 1995:691-707

Lloyd Dunlap

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