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PrabotulinumtoxinA-xvfs Injection (Jeuveau)
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Drs. Elliott and Chan report no financial relationships relevant to this field of study.
The FDA has approved a botulinum neurotoxin type A for the treatment of glabellar lines (wrinkles between eyebrows). PrabotulinumtoxinA-xvfs will be launched as an alternative to onabotulinumtoxinA (Botox) for this indication. PrabotulinumtoxinA-xvfs was developed in South Korea from wild-type Clostridium botulinum , resulting in a product of higher purity than onabotulinumtoxinA (> 98% vs. 95%). 1 The new product will be marketed as Jeuveau.
INDICATIONS
PrabotulinumtoxinA-xvfs is indicated for temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. 2
DOSAGE
The recommended dose is 0.1 mL (four units) by intramuscular injection into each of five sites for a total of 20 units. 2 PrabotulinumtoxinA-xvfs is available as a single-dose vial containing 100 units of vacuum-dried powder.
POTENTIAL ADVANTAGES
PrabotulinumtoxinA-xvfs is expected to be cheaper than onabotulinumtoxinA for the treatment of glabellar lines.
POTENTIAL DISADVANTAGES
The label states that prabotulinumtoxinA-xvfs is not interchangeable with other botulinum toxin A products. 2
COMMENTS
The efficacy and safety of prabotulinumtoxinA-xvfs were evaluated in two randomized, double-blind, placebo-controlled trials of identical design. 2-4 Adults with glabellar lines of at least moderate severity at maximum frown were randomized to a single treatment of prabotulinumtoxinA-xvfs (n = 246) or placebo (n= 84). The primary endpoint, assessed on day 30, was defined as the proportion of subjects achieving ≥ 2-grade improvement from baseline at maximum frown. This was assessed by both the investigator and the subject using a four-point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Composite responder rates were 67% and 71% for prabotulinumtoxinA-xvfs and 1% in both studies for placebo. Headache was the most common adverse reaction, which occurred at a frequency of 12% in...