Approval is supported by positive results from three completed phase 3 trials that enrolled more than 1000 subjects in the U.S. and Europe
NEWPORT BEACH, Calif., November 28, 2022--(BUSINESS WIRE)--Hugel America, Inc., (Hugel Aesthetics), today announced it received Therapeutic Goods Administration (TGA) approval for LETYBO (letibotulinumtoxinA) to treat moderate-to-severe glabellar (frown) lines in adults.
"We are thrilled with the TGA’s approval of LETYBO. This is a major milestone for Croma Australia as we focus on becoming a top aesthetics brand in Australia," stated James Hartman, President, Hugel Aesthetics. "We are excited to deliver quality aesthetic solutions that are accessible and attainable, and we look forward to contributing to the expansion of the Australian medical aesthetics market."
Steven Liew, world-renowned Plastic Surgeon, and Medical Director of Shape Clinic in NSW, stated, "Australia is in a unique position. We are a very small country by population, yet we are one of the top countries in adopting non-surgical rejuvenation therapy. Australians are curious and strive to look their best, perhaps due to our outdoor lifestyle. The addition of LETYBO, which TGA has recently approved, will significantly contribute to the aesthetic market. To me, it's all about choice. It's all about having another quality, anti-wrinkle injection to choose from; so that, as practitioners, we can provide the best outcome for our patients by assisting them to choose the best treatment for their needs."
LETYBO has been the market leader for six consecutive years in South Korea, one of the world’s most dynamic aesthetic markets, and is now available in 44 countries.
LETYBO is expected to be available in Australia 1H 2023. Injectors are encouraged to contact their Croma Australia account manager or email email@example.com for information.
LETYBO is indicated for temporary improvement in the appearance of moderate to severe glabellar frown lines in adults.
Healthcare professionals and patients can contact Hugel’s Medical Information team for further information at firstname.lastname@example.org or by phone at 1800 276 622.
About Hugel Aesthetics/Croma Australia
Croma Australia Pty Ltd is a subsidiary of Hugel Aesthetics, a division of the global medical aesthetics leader, Hugel, Inc., focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, and Australia. Hugel Aesthetics is dedicated to making a difference by transforming patient experiences. For more information, visit us at www.hugel-aesthetics.com
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