The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the marketing authorisation application for Evolus’ botulinum toxin type A formulation.
Approved by the US Food and Drug Administration in February for the temporary improvement in the appearance of moderate to severe glabellar lines, Nuceiva prabotulinumtoxinA (branded Jeuveau in the US and known in other markets as Nabota) is manufactured by the US-based medical aesthetic company Evolus Inc and is the company’s first and only product.
By receiving scientific recommendation for marketing by the CHMP, the EU Commission will now review the advice and deliver its final decision on the company’s marketing authorisation application. A final decision from the European Commission usually takes around 60 days and once made, the decision will be applicable to all 28 EU Union member states, plus Iceland, Norway and Liechtenstein.
Following the announcement, shares for Evolus grew by 2%.
David Moatazedi, President and Chief Executive Officer of Evolus said, “The receipt of the CHMP positive opinion further validates the rigor of our transparency clinical development programme, which includes the largest aesthetics head-to-head pivotal study versus Botox. In anticipation of approval of Nuceiva, we continue to evaluate commercial partnership opportunities in Europe. We have now achieved success with our regulatory filings for Jeuveau/Nuceiva in the United States, Canada and the European Union.”