FDA approves new toxin for use in glabellar lines
The US Food and Drug Administration (FDA) has approved Jeuveau, a new botulinum toxin type A, for the temporary improvement in the appearance of moderate to severe glabellar lines. The product is manufactured by US-based company Evolus. The FDA approval was supported by clinical data from US Phase III randomised, multi-centre, double-blind placebo-controlled clinical trials. It was reported that 67.5% of subjects in study one and 70.4% of subjects in study two met the primary endpoint, compared to 1.2% and 1.3% of patients in each placebo arm respectively.
David Moatazedi, President and Chief Executive Officer of Evolus, stated, “Evolus is the first company in nearly a decade to enter the fast-growing U.S. 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.”
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.”
Jeuveau™ is expected to be available throughout the United States at physician offices starting in Spring 2019.