Hugel America, Inc. Announces Successful Completion of Croma-Pharma’s Decentralized Procedure for Letybo® (LetibotulinumtoxinA for Injection) in Europe
28 January 2022
Hugel America, Inc., a growth-focused joint venture between aesthetic market-leading partners Hugel Inc., and Croma-Pharma GmbH (Croma), announced that Croma has completed the decentralized procedure in Europe for Letybo® (LetibotulinumtoxinA for Injection) to treat glabellar (frown) lines.
The Letybo® submission in Europe is based on the data of three completed randomized, placebo-controlled phase III trials that enrolled more than 1000 subjects in the US and Europe. National phases to grant market authorization across Europe are following now.
“We are thrilled for our colleagues at Croma and believe this is a critical milestone in furthering their comprehensive portfolio to meet the needs of health care providers and consumers throughout Europe,” said James Hartman, President, Hugel America. “Additionally, we continue to look forward to our US FDA Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2022.”
LetibotulinumtoxinA for injection is developed and produced by Hugel, Inc. and is licensed by Croma for commercialization throughout Europe. This botulinum toxin type A has been the market leader for six consecutive years in South Korea, one of the world’s most dynamic aesthetic markets.
About Hugel America, Inc. (Hugel Aesthetics)
Hugel America, Inc. (Hugel Aesthetics) is a growth-focused joint venture between aesthetic marketing leading partners, Hugel, Inc and Croma-Pharma GmbH, focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, Australia, and New Zealand. Hugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: www.hugel-aesthetics.com
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