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news.US-based Kythera Biopharmaceuticals has submitted a regulatory application to Australia's Therapeutic Goods Administration (TGA) for its new submental contouring injectable drug ATX-101 (deoxycholic acid) to improve submental fullness associated with submental (under the chin) fat.
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The submission is part of the company’s ATX-101 global development program and follows regulatory applications in the US, Canada and Switzerland.
In Australia, the regulatory application was supported by results from two pivotal Phase III trials, REFINE-1 and REFINE-2.
Results from these trials showed that 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.
Kythera president and chief executive officer Keith Leonard said: "Kythera is committed to making ATX-101 available in key markets to treat submental fullness, an often-cited yet under-addressed condition that can occur regardless of a person’s weight.
"We plan additional submissions to regulatory authorities in other countries during the remainder of this year."
The US Food and Drug Administration’s (FDA) Dermatology and Ophthalmic Drugs Advisory Committee is scheduled to review the company’s new drug application (NDA) for ATX-101 (deoxycholic acid) in March 2015 for ‘improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults’.
The company is focused on the discovery, development and commercialization of new prescription products for the aesthetic medicine market.