Letybo FDA Approval History
Last updated by Judith Stewart, BPharm on March 25, 2024.
FDA Approved: Yes (First approved February 29, 2024)
Brand name: Letybo
Generic name: letibotulinumtoxinA-wlbg
Dosage form: Powder for Injection
Company: Hugel, Inc.
Treatment for: Glabellar Lines
Letybo (letibotulinumtoxinA-wlbg) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
- Glabellar lines are excessive lines or wrinkles caused by small muscles (including corrugator and procerus) between the eyebrows and in the forehead, an area called the glabella. Glabellar lines can make a person look sad or angry even when they're not.
- Letybo is a botulinum neurotoxin that works to reduce the underlying muscle activity that causes glabellar lines by inhibiting the release of acetylcholine to block cholinergic transmission at the neuromuscular junction.
- Letybo is administered by intramuscular injection into each of five sites (the inferomedial and superior middle of each corrugator and one in the mid-line of the procerus muscle).
- Letybo comes with a Boxed Warning for the distant spread of the toxin effect that can occur hours to weeks after injection, and can include potentially life threatening swallowing and breathing difficulties.
- The most common adverse reaction is headache.
Development timeline for Letybo
| Date | Article |
|---|---|
| Mar 4, 2024 | Approval FDA Approves Letybo (letibotulinumtoxinA-wlbg) for the Treatment of Glabellar Lines |
Further information
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