Daewoong Pharmaceutical’s botulinum toxin about to be released in Europe with European CHMP’s recommendation for approval

Daewoong Pharmaceutical’s botulinum toxin about to be released in Europe with European CHMP’s recommendation for approval. - Received ‘recommendation for approval’ from EMA-affiliated CHMP. - Expected to be the first Korean Botulinum Toxin formula to be released in the world’s largest U.S. and European markets. Daewoong Pharmaceutical’s ‘Nabota,’ an independently developed Botulinum Toxin, has opened the gateway to the European market after the U.S. Daewoong Pharmaceutical (CEO Sengho Jeon) announced that ‘Nabota’ (product name for Europe: Nuceiva) was approved for Glabellar lines by the Committee for Medicinal Products for Human Use (CHMP) affiliated by the European Medicines Agency (EMA) on April 26 (local time). ‘Nabota’ is the Botulinum Toxin formula released in Korea by Daewoong Pharmaceutical back in 2014 and the only Korean Botulinum Toxin to be approved by the U.S. FDA under the name, JEUVEAU last February.  With CHMP’s recommendation for approval, its release in the European market as the world’s second Botulinum Toxin is just around the corner. CHMP is an organization that discusses whether to approve pharmaceuticals based on scientific evaluation of efficacy, safety, and other properties to suggest its opinion to the European Commission (EC).  The EC makes the final decision about the approval within 3 months of CHMP’s recommendation. Once the EC makes the final decision, the botulinum toxin manufactured by Daewoong Pharmaceutical can be sold in 28 countries within the EU and three EEA countries, Norway, Iceland, and Liechtenstein.  That will be a total of 31 countries in Europe.  The license of sales concerning Nuceiva in Europe is held by Evolus, which is the Daewoong Pharmaceutical’s partner in North America and Europe. “CHMP’s recommendation for approval has confirmed excellence in quality, safety, and efficacy proven by the global clinical studies of botulinum toxin manufactured by Daewoong Pharmaceutical and we are positive about the final approval for sale in Europe after the U.S.,” said CEO Sengho Jeon of Daewoong Pharmaceutical.  “The U.S. and Europe takes over 70% of the world’s Botulinum Toxin market, so another release in Europe will strengthen its brand name as a global brand.” #  #  # ​

The release as fetched from its publisher. daewoong.co.kr ↗