NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)
RegulatorypositiveUbesloEvlarcoPositive
AI Analysis
Summary
NewAmsterdam Pharma and Menarini Group received a positive CHMP opinion recommending marketing authorization for obicetrapib monotherapy (Ubeslo) and obicetrapib/ezetimibe fixed-dose combination (Evlarco) in Europe, based on positive Phase 3 data. European Commission decision is expected in the second half of 2026.
Clinical Trial Data
Phase
Phase 3
Primary Endpoint
Met
Outcome Details
Positive CHMP opinion recommending marketing authorization for obicetrapib monotherapy and obicetrapib/ezetimibe fixed-dose combination
Importance:8/10
Sentiment:
0.85
CHMP OpinionEuropean ApprovalObicetrapibFixed-Dose CombinationPhase 3 DataMarketing Authorization
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Published by PR Newswire Clinical Trials on July 24, 2026 2:13 PM