Home Medizin FDA genehmigt weiteres Neurotoxin gegen Zornesfalten

FDA genehmigt weiteres Neurotoxin gegen Zornesfalten

von NFI Redaktion

The Food and Drug Administration (FDA) has approved LetibotulinumtoxinA-wlbg, an injectable neurotoxin that has long been used in South Korea for the treatment of moderate to severe glabellar lines (forehead wrinkles) in adults. The product, developed by Hegel, is marketed under the brand name Letybo.

The FDA approval was based on positive results from three Phase-3 studies with LetibotulinumtoxinA-wlbg, involving over 1000 individuals in the United States and Europe. The most common side effect reported in the studies was headaches, occurring in 2% of study participants. Other adverse events reported by less than 1% of study participants included eyebrow ptosis, eyelid ptosis, and blepharospasm, while the most commonly reported reactions at the injection site included swelling at the administration site, facial pain, folliculitis, and periorbital hematoma.

According to a company press release, LetibotulinumtoxinA-wlbg has been the leading neurotoxin brand in South Korea for seven consecutive years and has been sold in over 50 different countries. Hugel plans to launch Letybo for aesthetic clinicians based in the USA in the second half of 2024.

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