Hugel’s Letybo wins marketing approval from Austria
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Austria is the second European company to grant the permission after the company got the 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 (EMA) is an active member of the HMA.
France allowed the sale of the product from Jan. 27. Hugel aims to enter a total of 11 countries, including Britain, Germany, Spain and Italy in the first quarter.
The size of European botulinum toxin market is estimated to be about 500 billion won ($420 million), the company said, and is expected to grow at an annual rate of 7.6 percent through 2025.
The United States, China and Europe dominate the world’s botulinum toxin market, accounting for over 80 percent of the sales.
Letybo won the use approval in China in October 2020. It is currently waiting for marketing approvals 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, last year. Hugel has been projecting final EMA approval within the first quarter and the first half of 2022 for the FDA.
BY SARAH CHEA [chea.sarah@joongang.co.kr]
with the Korea JoongAng Daily
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