Evolus receives regulatory approval for Nuceiva in Australia

Evolus announced that the Australian Therapeutic Goods Administration TGA has provided regulatory approval for Nuceiva, prabotulinumtoxinA, a neurotoxin dedicated exclusively to aesthetics. Nuceiva was approved for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. Glabellar lines are the vertical lines between the eyebrows seen at maximum frown. "We are thrilled to gain regulatory approval for Nuceiva in Australia, one of the largest market opportunities for aesthetic neurotoxins outside of the United States, where we are rapidly gaining market share, and Great Britain, where we recently launched commercial operations," said David Moatazedi, President and Chief Executive Officer, Evolus. "This approval is the latest example of our commitment to broaden our international presence, which is a key component to reaching our aspiration of $500 million in total revenue by 2028." Evolus plans to launch Nuceiva in Australia during the second half of 2023 after commencing additional launches in Europe – beginning with Germany and Austria – in the first half of 2023. In addition to Great Britain, Nuceiv is also commercially available in Canada. The safety and efficacy of Nuceiva was evaluated through the company’s global TRANSPARENCY clinical program, which included two Phase III U.S. trials, the largest head-to-head aesthetic pivotal study versus BOTOXor onabotulinumtoxinA to date, and two long-term safety studies. The product is approved for sale in the U.S. under the brand name Jeuveau.