Menarini Group und NewAmsterdam Pharma erhalten von der Europäischen Kommission die Zulassung für Ubeslo® (Obicetrapib als Monotherapie) und Evlarco® (Fixkombination aus Obicetrapib und Ezetimib)
RegulatoryapprovedUbesloEvlarcoPositive
AI Analysis
Summary
The European Commission approved Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe combination) developed by Menarini Group and NewAmsterdam Pharma, marking the first worldwide approval of obicetrapib as a first-in-class CETP inhibitor. The approvals are supported by Phase 3 trials (BROADWAY, BROOKLYN, TANDEM) demonstrating significant LDL-C reduction with good tolerability.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
European Commission approval for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib and ezetimibe fixed combination) as first-in-class CETP inhibitor
Importance:9/10
Sentiment:
0.95
regulatory approvalEuropean Commissionfirst-in-classCETP inhibitorPhase 3 datacardiovascular
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Published by PR Newswire Clinical Trials on September 21, 2026 7:04 PM