Apr 01, 2019
Evolus Provides Regulatory Update on Nuceiva™ in the European Union
Nuceiva™ (branded Jeuveau™ in
“We are actively addressing the CHMP’s final few questions in accordance with their timelines, which will enable them to adopt their formal opinion on our MAA during the April Committee meeting,” said
The CHMP opinion is a scientific recommendation for marketing authorization to the
About Nuceiva™ (branded Jeuveau™ in
Nuceiva™ (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation. Nuceiva™ is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Nuceiva™. The safety and efficacy of Nuceiva™ has been evaluated in clinical studies with over 2,100 patients enrolled. Nuceiva™ is being evaluated by the EMA for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved Jeuveau™ (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau™ is powered by Evolus' unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995 including statements related to the regulatory status of Nuceiva™. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “planned,” “expect,” “believes,” “strategy,” “opportunity,” “anticipates,” “outlook,” “designed,” and similar words. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including risks and uncertainties related to the regulatory process for Nuceiva™ in
Hi-Pure™ is a trademark of
Jeuveau™ and Nuceiva™ are trademarks of
Vice President, Finance, Investor Relations & Treasury