Daewoong Pharmaceutical's self-developed botulinum toxin "Nabota" opened the door for the European market following the U.S.
Daewoong Pharmaceutical said on April 26 (based on local time) that it received the recommendation of approval for the treatment efficacy of Nabota(Nuceiva in Europe/Jeaveau in U.S.) for frown lines and wrinkles around the eye area from the Committee for Medicinal Products for Human Use (CHMP) placed under the European Medicines Agency ( EMA).
Nabota is a botulinum toxin product released in Korea by Daewoong Pharmaceutical in 2014 and was the first Korean botulinum toxin product to win a permission from the U.S. Food and Drug Administration in February.
Following the CHMP's recommendation, Nabota is also set to advance into the European market, the world's second largest botulinum toxin market.
CHMP is an organization that provides its opinion to the European Commission (EC) based on the results of scientific assessments such as effectiveness and safety of medicines, and within three months of the CHMP's recommendation, the executive committee makes a final decision on whether to grant the sale.
Once the executive committee makes a final approval decision, Nabota will be available for sales in a total of 31 European countries, including 28 countries in the European Union and three European Economic Zone (EEA), which includes Norway, Iceland and Liechtenstein. Nabota's European copyright is held by its North American and European partner, Evolus.
"The CHMP's recommendation for permission is a positive result of the re-certification of quality, safety and validity found in Nabota's global large-scale clinical studies, and we expect the final sales approval in Europe after the United States. The U.S. and Europe account for more than 70 percent of the global botulinum toxin market, which will further strengthen Nabota's status as a global brand," Daewoong Pharmaceutical CEO Jeon Seng-ho said.