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news.US-based Kythera Biopharmaceuticals has submitted a New Drug Submission (NDS) to Health Canada seeking approval for its investigational drug candidate, ATX-101 (deoxycholic acid), as an injectable treatment to reduce submental fat.
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The NDS is based on results from two pivotal Phase III trials, REFINE-1 and REFINE-2, which were reported in late 2013.
In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and showed significant improvement in the visual and emotional impact of treatment.
Kythera president and chief executive officer Keith Leonard said the latest regulatory submission is yet another significant milestone for the company’s global ATX-101 development program.
"While the area under the chin is visually important to patients, there are no approved non-surgical options available to reduce submental fat," Leonard said.
"Canada has a very mature aesthetic market with several toxins and fillers approved. If approved, ATX-101 can fulfill an unmet need as a first-in-class submental contouring drug for patients in Canada."