2019年04月29日，Evolus是一家医学美容公司，致力于为医师及其患者提供突破性的美容产品。近日，该公司宣布，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）已发布积极审查意见，推荐批准Nuceiva（prabotulinumtoxinA-xvfs），用于65岁以下成年人，暂时改善与皱眉肌和/或降眉间肌活动相关的中度至重度皱眉纹（glabellar lines）的外观。现在，CHMP的意见将递交至欧盟委员会（EC），后者将参考CHMP的意见并在未来2-3个月做出最终审查决定。
在美国，Nuceiva的品牌名为Jeuveau，于2019年2月获批，用于成人暂时改善中度至重度皱眉纹，此次批准，使Jeuveau成为美国批准的首个专门用于美学的神经毒素产品。此前，Jeuveau于2018年8月也获得了加拿大卫生部批准，Evolus公司已计划在2019年上半年将Jeuveau推向美国和加拿大市场，该药将为美容医生及其患者提供一个非常具有吸引力的新治疗选择。
Nuceiva的全球性临床开发项目TRANSPARENCY共入组了全球2100多例患者，包括2项美国关键性III期研究、一项欧洲&加拿大III期头对头研究、2项长期安全性研究。其中，欧洲&加拿大III期头对头研究是迄今为止规模最大的评估与Botox的头对头美学关键性研究。
Evolus总裁兼首席执行官David Moatazedi表示，“CHMP的积极意见进一步证实了我们TRANSPARENT临床开发项目的严格性，该项目包括与保妥适（Botox）对比的最大规模美学头对头关键性研究。随着Nuceiva在欧洲的预期批准，我们将继续评估欧洲市场的商业合作机会。”
Nuceiva/Jeuveau是一种注射型900千道尔顿（kDa）肉毒杆菌A型肉毒毒素，旨在满足日益增长的面部美容市场的需求。Evolus认为，Nuceiva/Jeuveau将为医师和患者提供一个非常有吸引力的治疗选择。
原文出处：EVOLUS RECEIVES POSITIVE CHMP OPINION FOR NUCEIVA? IN THE EUROPEAN UNION
European Commission Approval Anticipated Within 90 Days
April 26, 2019 (GLOBE NEWSWIRE) -- Evolus, Inc. EOLS, -7.86% a performance beauty company with a customer-centric approach focused on delivering breakthrough products, today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the Nuceiva(TM) marketing authorization application.
The CHMP opinion is a scientific recommendation for marketing authorization to the European Commission, which will now review the recommendation and deliver its final decision on the Company's marketing authorization application. The decision will be applicable to all 28 European Union member states plus Iceland, Norway and Liechtenstein.
"We are pleased to receive a positive CHMP opinion and look forward to receiving final expected approval of our marketing authorization application," said Rui Avelar, MD, Chief Medical Officer and Head of Research & Development.
Nuceiva(TM) (branded Jeuveau(TM) in the United States) is a proprietary 900 kDa purified botulinum toxin type A formulation 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.
"The receipt of the CHMP positive opinion further validates the rigor of our TRANSPARENCY clinical development program, which includes the largest aesthetics head-to-head pivotal study versus BOTOX [(R)] . In anticipation of approval of Nuceiva(TM), we continue to eva luate commercial partnership opportunities in Europe," said David Moatazedi, President and Chief Executive Officer. "We have now achieved success with our regulatory filings for Jeuveau(TM)/Nuceiva(TM) in the United States, Canada and the European Union."
About Nuceiva(TM) (branded Jeuveau(TM) in the United States)
Nuceiva(TM) (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation. Nuceiva(TM) is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Nuceiva(TM). The safety and efficacy of Nuceiva(TM) has been eva luated in clinical studies with over 2,100 patient |
