Evolus Receives Approval for Nuceiva™ in the European Union
- Category: Proteins and Peptides
- Published on Wednesday, 02 October 2019 11:02
- Hits: 1197
NEWPORT BEACH, CA, USA I October 01, 2019 I Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced that the European Commission (EC) has approved the marketing of Nuceiva™ (prabotulinumtoxinA). Similar to other neurotoxins marketed in Europe, Nuceiva™ is approved 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 facial lines has an important psychological impact in adults below 65 years of age. The EC decision is applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.
“With the approval in Europe, we have now achieved all key R&D milestones around the world,” said Rui Avelar, MD, Chief Medical Officer and Head of Research & Development. “This approval further validates our TRANSPARENCY clinical development program, which included the largest aesthetics head-to-head pivotal study conducted in Europe and Canada versus BOTOX® out to 150 days.”
The product was approved by the United States Food and Drug Administration in February 2019 and launched under the brand name, Jeuveau®, in May 2019. Nuceiva™ was approved by Health Canada in August 2018. The company expects to launch Nuceiva™ in Canada in the fourth quarter through its partner Clarion. The company also expects Nuceiva™ to launch in Europe in 2020.
Nuceiva™ (prabotulinumtoxinA) 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™ was granted marketing authorization by the EC 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.