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Daewoong’ BTX gains European approval

US’s Evolus to begin sales of Nuceiva in 38 European countries in 2020

Daewoong Pharmaceutical’s botulinum toxin Nuceiva was greenlighted by the European Commission for commercialization, Daewoong said Wednesday.

US’ Evolus, the exclusive partner of Daewoong, plans to roll out Nuceiva in Europe from 2020 as forehead wrinkle smoothening treatment. Nuceiva is known as Navota in Korea and Jeuveau in the US. 


Daewoong Pharmaceuticals
Daewoong Pharmaceuticals


Daewoong put emphasis on having made inroads to both US and Europe markets, which together account for approximately 70 percent of the world’s BTX market.

“The approval from the US and Europe testify to the worldwide recognition of Navota‘s quality, safety and efficacy,” said a Daewoong representative.

“Through Navota, Daewoong will contribute to raising Korean pharmaceuticals’ status in the global stage,” the representative said.

In the US, the Food and Drug Administration approved the commercialization for Daewoong’s BTX in February. The launch followed in May.

In Europe, Nuceiva will become available in a total of 31 countries including the 28 EU nations and Norway, Iceland and Liechtenstein.

Nuceiva also gained approval from Health Canada in August 2018 and is counting down to launch there in the fourth quarter of 2019.

Meanwhile, Daewoong and Evolus have an ongoing lawsuit in Korea and in the US regarding the origin of its BTX toxin, brought by Korea’s Medytox and its US partner Allergan.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)
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