The Food and Drug Administration (FDA) has approved Jeuveau (prabotulinumtoxinA-xvfs; Evolus) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
Jeuveau, an aesthetic-only neurotoxin, was evaluated in 2 US phase 3 placebo-controlled trials and a European and Canadian phase 3 head-to-head trial vs onabotulinumtoxinA (Botox Cosmetic; Allergan). In both US trials, Jeuveau demonstrated efficacy compared with placebo in the reduction of the severity of glabellar lines, defined as a 2-point composite improvement agreed upon by physician and patient, at Day 30 (primary endpoint). Results showed that in Study 1 (EV-001), 67.5% of patients met the primary endpoint vs 1.2% of the placebo arm; in Study 2 (EV-002), 70.4% of patients met the primary endpoint vs 1.3% of placebo patients.
Commenting on TRANSPARENCY, the Jeuveau clinical program which included over 2100 patients, Ava Shamban, MD, Board Certified Dermatologist and clinical investigator, said, “The outcomes I’ve seen for my clinical trial patients firsthand, combined with the comprehensive clinical data set for Jeuveau provide a compelling new treatment option for physicians and their aesthetic patients. Importantly, there were no serious drug related adverse events reported.”
Jeuveau for Injection, a proprietary 900 kDa purified botulinum toxin type A formulation, is expected to be available in Spring 2019.
For more information visit evolus.com.