JEUVEAU
JEUVEAU (prabotulinumtoxinA-xvfs) is a neuromuscular blocking agent and acetylcholine release inhibitor. It is indicated for adult patients to achieve temporary improvement in the appearance of moderate to severe glabellar lines. The treatment specifically addresses lines associated with the activity of the corrugator and procerus muscles. By reducing localized muscle activity, the drug provides a temporary aesthetic modification for these facial features.
How JEUVEAU Works
JEUVEAU blocks neuromuscular transmission by binding to motor nerve terminals and inhibiting the release of acetylcholine. This inhibition is achieved by cleaving SNAP-25, a protein essential for the docking and release of acetylcholine from nerve ending vesicles. Intramuscular injection produces partial chemical denervation, resulting in a localized reduction in muscle activity. The effect is eventually reversed as reinnervation of the muscle occurs.
Details
- Status
- Prescription
- First Approved
- 2019-02-01
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
JEUVEAU Approval History
What JEUVEAU Treats
1 indicationsJEUVEAU is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Glabellar Lines
JEUVEAU Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. [ See Warnings and Precautions ( 5.1 )...
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. [ See Warnings and Precautions ( 5.1 ) ] WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines. ( 5.1 )
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JEUVEAU FDA Label Details
ProIndications & Usage
FDA Label (PDF)JEUVEAU is 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. JEUVEAU 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
WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including JEUVEAU, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing diffic...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.