1 February 2019 - Jeuveau is the first aesthetic-only neurotoxin approved in the U.S; launch planned for spring 2019.

Evolus today announced that the U.S. FDA has approved its lead product, Jeuveau, for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

Ava Shamban, MD, Board Certified Dermatologist and clinical investigator, commented, “The outcomes I’ve seen for my clinical trial patients firsthand, combined with the comprehensive clinical data set for Jeuveau provide a compelling new treatment option for physicians and their aesthetic patients. The TRANSPARENCY program involved the study of over 2,100 patients globally, which included two U.S. pivotal Phase III trials and a European & Canadian Phase III head-to-head trial versus Botox, in which all the primary and secondary endpoints were met. Importantly, there were no serious drug related adverse events reported. The comprehensive data set generated by Evolus through the TRANSPARENCY clinical program will give my peers the utmost level of confidence in providing Jeuveau to their patients. I look forward to incorporating Jeuveau into my aesthetic product offering.”

Read Evolus press release