The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use recommended granting marketing authorization for botulinum toxin type A (Nuceiva, Evolus Pharma Ltd) for the temporary improvement of vertical lines between the eyebrows in patients younger than 65 years who experience significant psychological effects from such lines.
Botulinum toxin type A will be available as a powder for injectable solution (100 U). Botulinum toxin type A, which is produced by the Clostridium botulinum bacteria, prevents muscle contraction by blocking the release of acetylcholine in the neuromuscular synapses.
Botulinum toxin type A is branded Jeuveau in the United States and was approved by the US Food and Drug Administration on February 1, 2019.
"The benefits with Nuceiva are its ability to temporally reduce the severity of the glabellar lines following local muscular paralysis," according to a summary of the committee's opinion.
The most frequently seen adverse effects are injection site reactions, eyelid ptosis, and headache.
The full indication is "for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.”
The committee proposes that botulinum toxin type A only be administered by physicians with experience treating glabellar lines, using the required equipment.
The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.
Cite this: EMA Panel Recommends Nuceiva for Glabellar Lines - Medscape - Apr 29, 2019.