CALABASAS, CA, USA I May 12, 2014 I KYTHERA Biopharmaceuticals, Inc. (KYTH) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin. Positive and consistent results from two pivotal Phase III trials — REFINE-1 and REFINE-2 — were reported in late 2013 and provide the basis for the NDA submission. In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.
“Since we began evaluating ATX-101 through our global clinical development program, it has demonstrated positive results in reducing fat under the chin, paired with an excellent safety profile and high patient satisfaction,” said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA. “We feel that ATX-101 has the opportunity to address a true unmet need in the U.S. aesthetic marketplace. We are excited to submit this new drug application for the FDA’s review.”
The global facial aesthetics market is estimated to reach $4.7 billion annually by 2018. While the area under the chin is visually important to patients, there are no approved non-surgical options available to reduce submental fat, leaving the area undertreated and patients unsatisfied. A double chin can be a tell-tale sign of aging, making individuals look older and heavier than they are and negatively impacting their overall appearance. If approved, ATX-101 would be a first-in-class submental contouring injectable drug for patients seeking to reduce fat under the chin.
“ATX-101 is at the center of our global commitment to bring real innovation supported by great science and clinical rigor to the growing field of aesthetic medicine,” says Keith Leonard, president and chief executive officer, KYTHERA. “The submission of this NDA represents another important milestone in the development of ATX-101 for the treatment of submental fat. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat, representing a new product category within facial aesthetics.”
Beyond this NDA submission, KYTHERA also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015. In March of this year, KYTHERA announced it acquired all rights to ATX-101 outside of the U.S. and Canada from Bayer Consumer Care AG, to which it had licensed the commercial rights for ATX-101 outside of U.S. and Canada in 2010.
About ATX-101
ATX-101 is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. It 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.i 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.
i Stryer L. Biosynthesis of membrane lipids and steroids. In: Biochemistry. New York, NY: WH Freeman and Co; 1995:691-707
About KYTHERA Biopharmaceuticals, Inc.
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’s product candidate, ATX-101, is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.
SOURCE: Kythera Biopharmaceuticals
Post Views: 117
CALABASAS, CA, USA I May 12, 2014 I KYTHERA Biopharmaceuticals, Inc. (KYTH) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin. Positive and consistent results from two pivotal Phase III trials — REFINE-1 and REFINE-2 — were reported in late 2013 and provide the basis for the NDA submission. In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.
“Since we began evaluating ATX-101 through our global clinical development program, it has demonstrated positive results in reducing fat under the chin, paired with an excellent safety profile and high patient satisfaction,” said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA. “We feel that ATX-101 has the opportunity to address a true unmet need in the U.S. aesthetic marketplace. We are excited to submit this new drug application for the FDA’s review.”
The global facial aesthetics market is estimated to reach $4.7 billion annually by 2018. While the area under the chin is visually important to patients, there are no approved non-surgical options available to reduce submental fat, leaving the area undertreated and patients unsatisfied. A double chin can be a tell-tale sign of aging, making individuals look older and heavier than they are and negatively impacting their overall appearance. If approved, ATX-101 would be a first-in-class submental contouring injectable drug for patients seeking to reduce fat under the chin.
“ATX-101 is at the center of our global commitment to bring real innovation supported by great science and clinical rigor to the growing field of aesthetic medicine,” says Keith Leonard, president and chief executive officer, KYTHERA. “The submission of this NDA represents another important milestone in the development of ATX-101 for the treatment of submental fat. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat, representing a new product category within facial aesthetics.”
Beyond this NDA submission, KYTHERA also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015. In March of this year, KYTHERA announced it acquired all rights to ATX-101 outside of the U.S. and Canada from Bayer Consumer Care AG, to which it had licensed the commercial rights for ATX-101 outside of U.S. and Canada in 2010.
About ATX-101
ATX-101 is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. It 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.i 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.
i Stryer L. Biosynthesis of membrane lipids and steroids. In: Biochemistry. New York, NY: WH Freeman and Co; 1995:691-707
About KYTHERA Biopharmaceuticals, Inc.
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’s product candidate, ATX-101, is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.
SOURCE: Kythera Biopharmaceuticals
Post Views: 117
