CHMP Recommends the EC to Approve Nabota
South Korea’s Daewoong Pharmaceutical Co. announced on April 26 that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has recommended that its botulinum toxin Nabota be approved for the treatment of frown lines.
The CHMP’s recommendation has brought Daewoong a step closer to selling Nabota (European name: Nuceiva, American name: Jeaveau) in the European market, which is the world’s second largest market.
Nabota is botulinum toxin launched by Daewoong in Korea in 2014. Last February, it became the first Korean botulinum toxin to be approved by the U.S. Food and Drug Administration (FDA).
The CHMP is an organization that advises the European Commission (EC) regarding approval of medicines. It presents its opinion based on scientific evaluation results, such as effectiveness and safety of medicines. The EC makes a final decision on sales approval within three months from CHMP’s recommendation date.
Once the EC approves Nabota, Daewoong will be able to sell it in a total of 31 European countries, including 28 countries in the European Union and 3 countries in the European Economic Area (EEA), which are Norway, Iceland and Liechtenstein. Nabota's European sales rights are owned by Evolus, Daewoong’s North America and European region partner.