The FDA has approved Jeuveau™ (prabotulinumtoxinA-xvfs), the lead product from Evolus, Inc., for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. It will be available to physicians this spring.
“Evolus is the first company in nearly a decade to enter the fast-growing US aesthetic neurotoxin market. What makes Evolus unique is our focus on delivering performance beauty products with a customer-centric approach. We are pleased to introduce Jeuveau™, the first FDA approved neurotoxin dedicated to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology,” says David Moatazedi, President and Chief Executive Officer of Evolus, in a statement.
Ava Shamban, MD, Board Certified Dermatologist and clinical investigator, comments, “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.”
Mr. Moatazedi anticipates publication of US Phase III results and to submit for publication a European and Canadian head-to-head Phase III study versus Botox®.
Updates will be available online.