By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco. Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
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.
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
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.
PrabotulinumtoxinA-xvfs is expected to be cheaper than onabotulinumtoxinA for the treatment of glabellar lines.
The label states that prabotulinumtoxinA-xvfs is not interchangeable with other botulinum toxin A products.2
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 both the drug and placebo groups.2 In a comparative, noninferiority study that included 265 patients, prabotulinumtoxinA-xvfs was noninferior to onabotulinumtoxinA.1 The Responder rates were 94% for prabotulinumtoxinA-xvfs and 89% for onabotulinumtoxinA. There were no differences in the incidence of adverse events between the two neurotoxins (20% vs. 18%).
PrabotulinumtoxinA-xvfs is a neurotoxin that produces a denervation and muscle inactivation. It has been available since 2002. Its approved indications (other than for cosmetic use) include axillary hyperhidrosis, cervical dystonia, chronic migraine prophylaxis, lower limb spasticity, overactive bladder, strabismus/blepharospasm associated with dystonia, upper limb spasticity, and urinary incontinence due to detrusor overactivity. It also has been used off label for conditions such as sialorrhea and achalasia.
PrabotulinumtoxinA-xvfs is the first competitor for onabotulinumtoxinA approved for glabellar lines. It is expected to be priced 20-25% lower and to be available in spring 2019.5
- Won CH, et al. Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: A multicenter, randomized, double-blind, active-controlled study. Int J Dermatol 2015;54:227-234.
- Evolus, Inc. Jeuveau Prescribing Information, February 2019. Available at: . Accessed March 11, 2019.
- ClinicalTrials.gov. A phase III study to demonstrate the safety and efficacy of DWP-450 to treat glabellar lines - EV001. Available at: . Accessed March 11, 2019.
- ClinicalTrials.gov. A phase III study to demonstrate the safety and efficacy of DWP-450 to treat glabellar lines - EV-002. Available at: . Accessed March 11, 2019.
- Mishra M. FDA approves cheaper Botox rival to treat frown lines. Reuters, Feb. 1, 2019. Available at: . Accessed March 11, 2019.