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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of Boey (trenibotulinumtoxinE, AbbVie) for the temporary improvement in the appearance of moderate to severe glabellar lines in adults when these lines have significant psychological impact.
Glabellar lines are the vertical wrinkles that form between the eyebrows, often called frown lines. In some adults, they can make the face look tired, angry, or worried and may also affect how a person feels about their appearance.
Boey contains trenibotulinumtoxinE, a botulinum toxin produced by the bacterium Clostridium botulinum. The active substance blocks the release of acetylcholine at neuromuscular synapses, preventing muscle cell contraction and temporarily reducing glabellar line severity through localized muscular paralysis.
Clinical Evidence
The CHMP announcement did not identify the studies, but company-reported phase 3 data from M21-500 and M21-508 evaluated the efficacy and safety of trenibotulinumtoxinE in adults with moderate to severe glabellar lines.
According to those data, both studies met their primary and secondary endpoints, with an onset of action reported as early as 8 hours after administration and an effect lasting 2-3 weeks. Treatment-emergent adverse events for trenibotulinumtoxinE were comparable to placebo, both after a single treatment and after up to three consecutive treatments.
Safety Profile and Next Steps
The most common side effects of Boey include eyelid ptosis, brow ptosis, and Mephisto sign, defined as lateral elevation of the eyebrow. Boey should only be administered by physicians with appropriate qualifications and expertise in treating glabellar lines and using the required equipment.
Boey will be available as a 1400-unit powder for solution for injection. Detailed recommendations for product use will be described in the summary of product characteristics, which will be published on the EMA website in all official European Union languages after marketing authorization has been granted by the European Commission.
