European Commission Approval Anticipated Within 90 Days
NEWPORT BEACH, CA, USA I April 26, 2019 I Evolus, Inc. (NASDAQ: EOLS), 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™ 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™ (branded Jeuveau™ 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®. In anticipation of approval of Nuceiva™, we continue to evaluate commercial partnership opportunities in Europe,” said David Moatazedi, President and Chief Executive Officer. “We have now achieved success with our regulatory filings for Jeuveau™ / Nuceiva™ in the United States, Canada and the European Union.”
About Nuceiva™ (branded Jeuveau™ in the United States)
Nuceiva™ (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation. Nuceiva™ is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Nuceiva™. The safety and efficacy of Nuceiva™ has been evaluated in clinical studies with over 2,100 patients enrolled. Nuceiva™ is being evaluated by the EMA 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.
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved Jeuveau™ (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau™ is powered by Evolus’ unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com.
SOURCE: Evolus
Post Views: 40
European Commission Approval Anticipated Within 90 Days
NEWPORT BEACH, CA, USA I April 26, 2019 I Evolus, Inc. (NASDAQ: EOLS), 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™ 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™ (branded Jeuveau™ 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®. In anticipation of approval of Nuceiva™, we continue to evaluate commercial partnership opportunities in Europe,” said David Moatazedi, President and Chief Executive Officer. “We have now achieved success with our regulatory filings for Jeuveau™ / Nuceiva™ in the United States, Canada and the European Union.”
About Nuceiva™ (branded Jeuveau™ in the United States)
Nuceiva™ (prabotulinumtoxinA-xvfs) is a proprietary 900 kDa purified botulinum toxin type A formulation. Nuceiva™ is produced under strict quality and safety standards in a state-of-the art facility, specifically built to manufacture Nuceiva™. The safety and efficacy of Nuceiva™ has been evaluated in clinical studies with over 2,100 patients enrolled. Nuceiva™ is being evaluated by the EMA 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.
About Evolus, Inc.
Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. In 2019, the U.S. Food and Drug Administration approved Jeuveau™ (prabotulinumtoxinA-xvfs), the first and only neurotoxin dedicated exclusively to aesthetics and manufactured in a state-of-the-art facility using Hi-Pure™ technology. Jeuveau™ is powered by Evolus’ unique technology platform and is designed to transform the aesthetic market by eliminating the friction points existing for customers today. Visit us at: www.evolus.com.
SOURCE: Evolus
Post Views: 40
