Hugel’s botulinum toxin product wins marketing approval in France

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Letybo, Hugel’s botulinum toxin product, won marketing approval from health regulators in France, the company said Thursday.

The green light came on Jan. 27, just two days after Hugel received an approval recommendation from the Heads of Medicines Agencies (HMA), a network of the heads of national authorities whose organizations are responsible for the regulation of medical products for human and veterinary use in the European economic area. European Medicines Agency is an active member of the HMA.

Hugel said it is very rare for a European country to give the permission so quickly as it normally takes about one to three months to approve a new drug after a HMA recommendation.

France will be the first European country that Letybo is exported to. Hugel aims to enter a total of 11 countries including Britain, Germany, Spain and Italy within the first quarter.

China granted sale approval for Letybo in October 2020. It is currently waiting for marketing approvals for the product from the U.S. Food and Drug Administration (FDA) and the EMA. The FDA and EMA concluded site inspections of the company’s manufacturing plant in Chuncheon, Gangwon, in August and October, respectively. Hugel has been projecting final EMA approval within the first quarter and the first half of 2022 for the FDA.

The botulinum toxin maker also applied for marketing authorization for Canada and Australia in July, and is expecting to gain approvals within the year.

Established in 2001, the company sells its botulinum toxin products to a total of 28 countries. The company is Korea's No. 1 botulinum toxin manufacturer in terms of sales since 2016, followed by No. 2 Medytox and then Daewoong Pharmaceutical.

BY SARAH CHEA [chea.sarah@joongang.co.kr]