Allergan Aesthetics receives positive CHMP opinion for Boey in glabellar lines

Allergan Aesthetics has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Boey for the temporary improvement in the appearance of moderate to severe lines between the eyebrows seen at maximum frown in adult patients, where these lines have an important psychological impact. A European Commission decision is expected in the coming months and, if granted, would apply across the 30 European Economic Area countries following completion of the centralised procedure.

“A positive opinion for Boey reflects years of scientific innovation and clinical development aimed at advancing botulinum toxin science,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “We strongly believe Boey has the potential to offer a differentiated treatment option for many people who are still considering facial injectables.”

The CHMP positive opinion is supported by data from two pivotal Phase 3 clinical trials evaluating the efficacy and safety of trenibotulinumtoxinE in adult subjects with moderate to severe glabellar lines (M21-500 and M21-508). All primary and secondary endpoints across the Phase 3 studies were met, with a rapid onset of action seen as early as eight hours after administration (the earliest assessment timepoint) and an observed efficacy duration of two to three weeks. Treatment emergent adverse events for trenibotulinumtoxinE were similar to placebo, both as a single treatment and across up to three consecutive treatments.

If approval is granted, Allergan Aesthetics plans to begin training healthcare professionals on the appropriate use of Boey and is preparing for a commercial launch in the months ahead. Marketing authorisation submissions for trenibotulinumtoxinE are also under review in several other countries.



Related Topics and Keywords

, , ,

Subscribe to our FREE newsletter and WEBINAR UPDATES

We will not sell or give your information to a third party. See our Privacy Policy