{"id":66054,"date":"2026-05-23T22:11:18","date_gmt":"2026-05-23T14:11:18","guid":{"rendered":"https:\/\/flcube.com\/?p=66054"},"modified":"2026-05-23T22:11:19","modified_gmt":"2026-05-23T14:11:19","slug":"allergan-aesthetics-secures-chmp-positive-opinion-for-boey-trenibotulinumtoxine-in-glabellar-lines-treatment-across-european-economic-area","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=66054","title":{"rendered":"Allergan Aesthetics Secures CHMP Positive Opinion for Boey (TrenibotulinumtoxinE) in Glabellar Lines Treatment Across European Economic Area"},"content":{"rendered":"\n

Allergan Aesthetics<\/strong>, an AbbVie company<\/strong> (NYSE: ABBV<\/a>), announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)<\/strong> has adopted a positive opinion<\/strong> recommending approval of Boey (trenibotulinumtoxinE)<\/strong> for the temporary improvement in the appearance of moderate to severe glabellar lines<\/strong> in adult patients when these have an important psychological impact.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>EMA\/CHMP (European Union)<\/td><\/tr>
Decision Type<\/strong><\/td>Positive opinion (recommendation for approval)<\/td><\/tr>
Product<\/strong><\/td>Boey (trenibotulinumtoxinE)<\/td><\/tr>
Indication<\/strong><\/td>Temporary improvement of moderate to severe glabellar lines with psychological impact<\/td><\/tr>
Geographic Scope<\/strong><\/td>30 European Economic Area (EEA) countries<\/td><\/tr>
Final Decision Timeline<\/strong><\/td>Expected within coming months<\/td><\/tr>
Approval Pathway<\/strong><\/td>Centralized procedure<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The European Commission’s final decision<\/strong>, expected in the coming months, would grant marketing authorization valid across all 30 European Economic Area (EEA) countries<\/strong>, significantly expanding Allergan Aesthetics’ neuromodulator portfolio in one of the world’s largest aesthetic markets.<\/p>\n\n\n\n

Clinical Evidence \u2013 Phase 3 Trial Results<\/h2>\n\n\n\n
Endpoint<\/th>Result (TrenibotulinumtoxinE)<\/th>Assessment Timepoint<\/th>Significance<\/th><\/tr><\/thead>
Primary Efficacy<\/strong><\/td>Met<\/td>Day 30<\/td>Statistically significant vs. placebo<\/td><\/tr>
Onset of Action<\/strong><\/td>Rapid onset observed<\/td>As early as 8 hours<\/td>Earliest assessment timepoint<\/td><\/tr>
Duration of Effect<\/strong><\/td>2-3 weeks<\/td>Multiple timepoints<\/td>Consistent across both studies<\/td><\/tr>
Safety Profile<\/strong><\/td>Similar to placebo<\/td>Single and multiple treatments<\/td>Favorable tolerability<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The CHMP positive opinion<\/strong> is supported by data from two pivotal Phase 3 clinical trials<\/strong> (M21-500<\/strong> and M21-508<\/strong>) evaluating the efficacy and safety of trenibotulinumtoxinE in adult subjects with moderate to severe glabellar lines. Both studies met all primary and secondary endpoints<\/strong>, demonstrating robust clinical performance.<\/p>\n\n\n\n

Safety Profile & Treatment Regimen<\/h2>\n\n\n\n