Daewoong Pharmaceutical said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Nabota, its botulinum toxin (BTX), for treating forehead wrinkles.
|Daewoong Pharmaceutical's botulinum toxin Nabota|
The positive opinion comes after the company obtained sales approval from the U.S. Food and Drug Administration in February of this year. Following the recommendation of the CHMP, the company is preparing to launch Nabota in the European market, which is the world's second BTX market.
The CHMP’s positive opinion is a scientific recommendation for marketing authorization to the European Commission, which will review it and issue a commission decision, valid in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. The commission decision will come within 67 days following the CHMP opinion.
If approved, Evolus, Daewoong’s U.S. and EU partner, will market the drug.
“The company expects to receive sales approval in Europe with the CHMP’s positive opinion, which is based on the superior quality, safety and efficacy of Nabota confirmed in global clinical trials,” Daewoong Pharmaceutical CEO Jeon Seng-ho said.
As the U.S. and Europe account for more than 70 percent of the global botulinum toxin market, Nabota's entries into the European market will further strengthen its position as a global brand, he added.