PrabotulinumtoxinA-xvfs

(Jeuveau®)

PrabotulinumtoxinA-xvfs

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Drug updated on 5/22/2024

Dosage FormInjection (intramuscular; 100 units/vial)
Drug ClassAcetylcholine 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.

Summary
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  • PrabotulinumtoxinA-xvfs (Jeuveau) is recommended for the temporary reduction of moderate to severe glabellar lines resulting from corrugator and/or procerus muscle activity in adult patients. Studies based on phase II and III clinical trials have shown that Jeuveau significantly improves these conditions, with 67.5% and 70.4% of participants achieving more than a 2-point enhancement on the Glabellar Line Scale at maximum frown from the baseline.
  • Two systematic reviews/meta-analyses compared Jeuveau with other botulinum toxin type A products for managing glabellar lines.
  • When evaluated against placebo groups, all botulinum toxin products reviewed showed a higher success rate by week four as assessed by participants or evaluators; however, Jeuveau exhibited notably higher response rates compared to these treatments.
  • The safety profile information suggests that Jeuveau is well tolerated in all studies, with no major adverse events reported shortly after treatment. This indicates a favorable safety profile in comparison to other Botulinum Toxin Type A products, which may present an increased risk of significant adverse events such as ptosis.
  • The studies primarily focused on adult patients aged between 18-65 years with moderate-to-severe glabella lines; a majority of the study participants were female, identifying this demographic as the primary group for these treatments. However, specific subgroup analyses based on age or gender are not detailed.
  • While both studies highlight a robust efficacy profile comparable among various botulinum toxin type A products, including Jeuveau, there is mention of a difference in safety among the drugs. Therefore, future direct comparisons and evaluations of long-term outcomes would be beneficial, especially concerning diverse subgroups within the adult population.

Product Monograph / Prescribing Information

Document TitleYearSource
Jeuveau (prabotulinumtoxinA-xvfs) Prescribing Information.2019Evolus Inc., Newport Beach, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Botulinum toxin type A for facial wrinkles. 2021The Cochrane Database of Systematic Reviews
PrabotulinumtoxinA-xvfs for the treatment of moderate-to-severe glabellar lines.2021Annals of Pharmacotherapy