KYTHERA Biopharmaceuticals, Inc. has announced on March 9, 2015 that the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. This medical condition is popular known as “Double Chin”.
If approved, ATX-101 would be a first-in-class submental contouring injectable drug for Double Chinned Patients in the US.
Fight Double Chin with ATX-101
“We are pleased that the FDA advisory committee recognized the importance of providing patients with a clinically-proven treatment option specifically developed to contour submental fullness, a much-cited yet undertreated facial aesthetic complaint,” said by Dr. Frederick C. Beddingfield. KYTHERA Biopharmaceuticals, chief medical officer, .
“We look forward to working with the FDA as they continue their review of ATX-101 with the goal of providing patients with the first and only approved non-surgical treatment for submental fullness.” Added Beddingfield.
Though not yet FDA approved. The recommendation by the committee will be a strong point in favor of ATX 101 towards being legally sold in the country. Experts are predicting the approval to come on the second half of 2015, at the latest.
What is ATX-101
ATX-101 is a patented formulation of a pure, non-animal derived version of deoxycholic acid. Deoxycholic Acid is a naturally occurring molecule in the body that aids in the breakdown of dietary fat.
ATX-101 has been tested on 19 clinical studies. Total population for all these clinical studies includes more than 2,600 patients and volunteers aging from 19 to 65 years old. BMI for patients rages from 18 to 40.
A New Drug Application or NDA was submitted to the U.S. Food and Drug Administration (FDA) in May 2014 and has a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015.
KYTHERA also submitted regulatory filings in various countries like Canada, Switzerland and Australia. If approved, ATX-101 would be a less-invasive, non-surgical option for the treatment of submental fullness.
Right now ATX 101 is still not approved by the US FDA.
We will updates you whenever is is already approved together with its cost of treatment, ATX 101 Price and Where to Buy!!!
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