NewAmsterdam Pharma and Menarini Group Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)
RegulatoryapprovedUbeslo®Evlarco®Positive
AI Analysis
Summary
NewAmsterdam Pharma and Menarini Group received European Commission approval for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination), supported by positive Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
European Commission approval for Ubeslo® (Obicetrapib monotherapy) and Evlarco® (Obicetrapib plus Ezetimibe fixed-dose combination)
Importance:9/10
Sentiment:
0.95
regulatory approvalEuropefirst-in-classPhase 3 datacardiovascularLDL-Clipid management
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Published by GlobeNewswire Pharma on September 21, 2026 1:00 PM