Drug updated on 9/4/2024
Dosage Form | Injection (intramuscular; 100 units/vial) |
Drug Class | Acetylcholine release inhibitors and neuromuscular blocking agents |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
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Summary
- Jeuveau (prabotulinumtoxina-xvfs) 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.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- PrabotulinumtoxinA-xvfs demonstrated significant improvement in the Glabellar Line Scale (GLS) at maximum frown by day 30, with response rates of 67.5% and 70.4%, compared to 1.2% and 1.3% in placebo groups (p < 0.001).
- PrabotulinumtoxinA-xvfs showed a slightly higher improvement rate in GLS at maximum frown on day 30 (87.2%) compared to onabotulinumtoxinA (82.8%) and placebo (4.2%) (p < 0.001).
- IncobotulinumtoxinA-20 U and daxibotulinumtoxinA-40 U demonstrated higher participant-assessed success rates (RR 66.57, 95% CI 13.50 to 328.28, and RR 21.10, 95% CI 11.31 to 39.34, respectively) and physician-assessed success rates (RR 134.62, 95% CI 19.05 to 951.45, and RR 23.40, 95% CI 12.56 to 43.61, respectively) compared to placebo.
- PrabotulinumtoxinA-xvfs (Jeuveau) was generally well tolerated across studies, with major adverse events (AEs) such as eyelid ptosis, strabismus, and eyelid sensory disorder being associated with Botulinum toxin type A. No major AEs were reported for incobotulinumtoxinA and daxibotulinumtoxinA, while onabotulinumtoxinA and abobotulinumtoxinA likely had higher incidences of major AEs compared to placebo.
- OnabotulinumtoxinA-20 U probably has a higher likelihood of major AEs compared to placebo (Peto OR 3.62, 95% CI 1.50 to 8.74), and abobotulinumtoxinA-50 U similarly shows an increased probability of major AEs (Peto OR 3.36, 95% CI 0.88 to 12.87). Major AEs are more probable in the abobotulinumtoxinA-50 U group than in the onabotulinumtoxinA-20 U group (Peto OR 2.65, 95% CI 0.77 to 9.09).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Jeuveau (prabotulinumtoxinA-xvfs) Prescribing Information. | 2019 | Evolus Inc., Newport Beach, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Botulinum toxin type A for facial wrinkles. | 2021 | The Cochrane Database of Systematic Reviews |
PrabotulinumtoxinA-xvfs for the treatment of moderate-to-severe glabellar lines. | 2021 | Annals of Pharmacotherapy |