Evolus Inc.'s Nuceiva, a rival to Allergan PLC's blockbuster wrinkle treatment Botox, was approved in the EU for the temporary improvement of frown lines.
The Newport Beach, Calif.-based medical aesthetics company said Nuceiva, or prabotulinumtoxinA, received the European Commission's approval for minimizing the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown.
Evolus' chief medical officer and head of research and development, Rui Avelar, said the approval confirms the company's clinical program, dubbed Transparency, which included the largest aesthetics head-to-head pivotal study conducted in Europe and Canada versus Botox for up to 150 days.
The product's approval was backed by a recommendation from the European Medicines Agency in April.
The company expects to launch Nuceiva — which is approved in the U.S. and sold by the name Jeuveau — in Canada in the fourth quarter via its partner Clarion, with a European market introduction slated for 2020.
Dublin-based Allergan — which is being acquired by AbbVie Inc. in an $84.2 billion deal — saw Botox generate about $3.58 billion in worldwide sales in 2018.
