KYTHERA files NDA for ATX-101 to reduce unwanted submental fat

The NDA submission is based on positive and consistent results from two pivotal Phase III trials – REFINE-1 and REFINE-2.

In these trials, which were reported in late 2013, 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 chief medical officer Frederick Beddingfield said since the company started assessing ATX-101 through its 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.

"We feel that ATX-101 has the opportunity to address a true unmet need in the U.S. aesthetic marketplace," Beddingfield said.

According to the company, the submission of this NDA represents another major milestone in the development of ATX-101 for the treatment of submental fat.

KYTHERA president and chief executive officer Keith Leonard said, "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."

If ATX-101 gets FDA approval, it will be the first non-surgical treatment for the reduction of submental fat, representing a new product category within facial aesthetics.

In addition to this NDA submission, the company also intends to make multiple ex-US regulatory submissions by the second quarter of 2015.

In March 2014, the company had acquired all rights to ATX-101 outside of the US and Canada from Bayer Consumer Care, to which it had licensed the commercial rights for ATX-101 outside of US and Canada in 2010.

Image: If approved by FDA, ATX-101 will be the first-in-class submental contouring injectable drug. Photo: courtesy of Baitong333/ freedigitalphotos.net