Menarini Group and NewAmsterdam Pharma Receive European Commission Approval for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)
RegulatoryapprovedUbesloEvlarcoPositive
AI Analysis
Summary
Menarini Group and NewAmsterdam Pharma received European Commission approval for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib plus ezetimibe fixed-dose combination), marking the first global regulatory approval of obicetrapib for LDL-C reduction. The approval is supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant efficacy 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). First global regulatory approval of obicetrapib.
Importance:9/10
Sentiment:
0.95
European Commission approvalFirst-in-classLDL-C reductionPhase 3 dataBROADWAY trialBROOKLYN trialTANDEM trial
Related Companies
Read the original article
Published by PR Newswire Pharma on September 21, 2026 2:57 PM