Newtox receives approval in the EU
Evolus, Inc., an exclusive partner of Daewoong Pharmaceutical for BTX, has announced that the European Commission (EC) has approved the marketing of Nuceiva™ (prabotulinumtoxinA). Nuceiva is also known as Jeuveau in the U.S. and Nabota in Korea.
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.
Nabota was approved by the United States Food and Drug Administration in February 2019 and launched under the brand name, Jeuveau®, in May 2019. Evolus is in charge of sales and marketing of the product in the USA.
Nuceiva™ was approved by Health Canada in August 2018. Evolas expects to launch Nuceiva™ in Canada in the fourth quarter through its partner Clarion.
“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 company also expects Nuceiva™ to launch in Europe in 2020.