The botulinum neurotoxin type E candidate is designed for a faster onset and shorter duration of effect than currently available neurotoxin treatments.
Allergan Aesthetics, an AbbVie company, announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Boey (trenibotulinumtoxinE) for the temporary improvement of moderate to severe glabellar lines in adults when the lines have an important psychological impact.
The recommendation applies to the 30 countries in the European Economic Area following completion of the centralized procedure. A decision from the European Commission is expected in the coming months.
Boey is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as eight hours after administration and short duration of effect of two to three weeks. According to AbbVie, if approved, Boey could become the first botulinum neurotoxin serotype E available for the temporary improvement of glabellar lines in adults.
“A positive opinion for Boey reflects years of scientific innovation and clinical development aimed at advancing botulinum toxin science,” says Roopal Thakkar, MD, executive vice president, research and development, chief scientific officer, AbbVie, in a release. “We strongly believe Boey has the potential to offer a differentiated treatment option for many people who are still considering facial injectables.”
The CHMP opinion is supported by data from two Phase 3 clinical trials evaluating the efficacy and safety of trenibotulinumtoxinE in adults with moderate to severe glabellar lines. According to the company, the studies met all primary and secondary endpoints, with results observed as early as eight hours after treatment and a duration of effect lasting two to three weeks.
AbbVie says treatment-emergent adverse events were similar to placebo following both a single treatment and up to three consecutive treatments.
If approved, Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey ahead of a commercial launch. Marketing authorization applications for trenibotulinumtoxinE are also under review in several other countries.
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