Evolus receives marketing approval in the EU for new botulinum toxin

04 Oct 2019

Medical aesthetic company Evolus Inc has announced that the European Commission (EC) has approved the marketing of Nuceiva prabotulinumtoxinA (branded Jeuveau in the US and known in other markets as Nabota).

The marketing has been approved for the temporary improvement in the appearance of moderate to severe glabellar lines. 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 research and development milestones around the world,” said Rui Avelar, chief medical officer and head of research and development at Evolus Inc.

He added, “This approval further validates our transparency clinical development programme, which included the largest aesthetics head-to-head pivotal study conducted in Europe and Canada versus Botox out to 150 days."

Aesthetics Clinical Advisory Board lead, and consultant plastic, reconstructive and aesthetic surgeon Mr Dalvi Humzah, said the approval is a very positive step for the UK aesthetic market. 

“I welcome a new botulinum toxin in the aesthetic arena. This marketing approval means that both patients and practitioners will have more choice and it opens further competition between the toxin companies. From a practitioner’s perspective, they need to consider that it’s only approved for the glabella for the moment; we know that this product has been used successfully in other markets so it will be very interesting to see what the future holds,” Mr Humzah said.


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