Le Groupe Menarini et NewAmsterdam Pharma obtiennent l'autorisation de la Commission européenne pour Ubeslo® (obicetrapib en monothérapie) et Evlarco® (association à dose fixe d'obicetrapib et d'ézétimibe)
RegulatoryapprovedUbesloEvlarcoPositive
AI Analysis
Summary
Le Groupe Menarini and NewAmsterdam Pharma received European Commission approval for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe combination), marking the first global regulatory authorization for obicetrapib, supported by Phase 3 trials demonstrating significant LDL-C reductions with favorable tolerability.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
European Commission authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe fixed-dose combination)
Importance:8/10
Sentiment:
0.95
regulatory approvalEuropean CommissionobicetrapibLDL-CPhase 3 datafixed-dose combination
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Published by PR Newswire Biotech on September 22, 2026 11:36 AM