General Information

Jeuveau (prabotulinumtoxinA-xvfs) is an acetylcholine release inhibitor and a neuromuscular blocking agent.

Jeuveau is specifically 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.

Jeuveau is supplied as an injection for intramuscular administration. Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites for a total dose of 20 units.

Mechanism of Action

Jeuveau (prabotulinumtoxinA-xvfs) is an acetylcholine release inhibitor and a neuromuscular blocking agent. Jeuveau blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, Jeuveau produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by Jeuveau.

Side Effects

Adverse effects associated with the use of Jeaveau may include, but are not limited to, the following:

• Headache
• Eyelid Ptosis
• Upper Respiratory Tract Infection
• Increase White Blood Cell count

The Jeaveau drug label comes with the following Black Box Warning: The effects of all botulinum toxin products, including Jeuveau, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. Jeuveau is not approved for the treatment of spasticity or any conditions other than glabellar lines.

Clinical Trial Results

The FDA approval of Jeuveau was based on clinical data from two U.S. Phase III randomized, multi-center, double-blind, placebo-controlled clinical trials.  The trials enrolled 654 subjects, randomized 3 to 1 to a single treatment with Jeaveau or placebo. Both trials met the primary endpoint and 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.  67.5% of subjects in study one (EV-001) and 70.4% of subjects in study two (EV-002) met the primary endpoint, compared to 1.2% and 1.3% of patients in each placebo arm respectively.