The FDA has approved a new botulinum toxin formulation for aesthetic use in the US. Letybo from Hugel America, Inc., a division of Hugel Inc., is approved to treat moderate-to-severe glabellar (frown) lines in adults.
Letybo (letibotulinumtoxinA-wlbg) is expected to launch in the second half of 2024. It has been the leading neurotoxin brand in South Korea for seven consecutive years.
FDA approval of the new toxin is supported by positive results from three completed phase III trials that enrolled more than 1,000 subjects in the US and Europe.
“The results from the clinical trials for letibotulinumtoxinA demonstrate efficacy, and a convincing safety profile in the treatment of glabellar lines,” says dermatologist Joely Kaufman, MD. “These comprehensive outcomes provide me–and will provide my fellow injectors– with a high level of confidence in offering Letybo to patients.”
