-

Croma Australia Pty Ltd, a subsidiary of Hugel Aesthetics, Receives TGA Approval in Australia for LETYBO (letibotulinumtoxinA) for the Treatment of Glabellar Lines

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.--(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 info@cromapharma.com.au for information.

INDICATION

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 medinfoau@hugel-aesthetics.com 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

Contacts

Kayleigh Adam, Alison Brod Marketing Communications, kayleigh@abmc-us.com
Peta Roberts, Croma Australia, peta.roberts@cromapharma.com.au

Hugel America, Inc.


Release Versions

Contacts

Kayleigh Adam, Alison Brod Marketing Communications, kayleigh@abmc-us.com
Peta Roberts, Croma Australia, peta.roberts@cromapharma.com.au

More News From Hugel America, Inc.

Hugel Aesthetics Receives FDA Acceptance of BLA Resubmission for LetibotulinumtoxinA for Injection for Glabellar Lines

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Hugel America, Inc. (Hugel Aesthetics) announced today the acceptance of its Biologics License Application for letibotulinumtoxinA, by the U.S. Food and Drug Administration (“FDA”). The FDA considered the resubmission a Class 2 response and has assigned a April 6, 2023 action date per the Prescription Drug User Fee Act (PDUFA). Jim Hartman, President of Hugel Aesthetics, stated, “We have worked diligently to advance our regulatory submission of letibotuli...

Hugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Hugel America, Inc. (Hugel Aesthetics) announced today that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for letibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines. The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in March 2022, which required additional data to complete the review of the BLA. Deficiencies cited by the FDA i...

Hugel Aesthetics to Present Data from Phase 3 Clinical Trial At 2022 American Society of Dermatologic Surgery Annual Meeting

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Hugel America, Inc. (Hugel Aesthetics) announced today that the company will have an oral presentation at the American Society for Dermatologic Surgery (ASDS) annual meeting (Oct. 6-10, 2022 in Denver, CO) highlighting data from its phase 3 clinical trial, BLESS III, assessing the efficacy of letibotulinumtoxinA in improving the psychosocial health-related quality of life (QoL) of subjects with moderate to severe glabellar lines. “Hyperfunctional glabella...
Back to Newsroom