Daewoong Pharmaceutical's botulinum toxin Nabota received a positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), Friday.
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.
A positive CHMP opinion is often a sure indication of EMA approval.
"US and Europe account for over 70 percent of the world's botulinum toxin market. Nabota's entry to Europe will bolster Nabota's global branding," said Daewoong's
Nabota, launched in Korea in 2014 by Daewoong, is marketed by Evolus in the US under the name Jeuveau. Jeuveau was approved by the US' Food and Drug Agency in February. In Europe, the botulinum toxin will sell under the name Nuceiva by Evolus.
By Lim Jeong-yeo (
kaylalim@heraldcorp.com)
