NewAmsterdam Pharma und die Menarini Group erhalten positive Stellungnahme des CHMP mit der Empfehlung zur Erteilung einer Zulassung für Ubeslo® (Obicetrapib-Monotherapie) und Evlarco® (Festsatzkombination aus Obicetrapib und Ezetimib)
RegulatorypositiveUbesloEvlarcoPositive
AI Analysis
Summary
NewAmsterdam Pharma and Menarini Group received a positive CHMP opinion recommending marketing authorization for obicetrapib monotherapy (Ubeslo) and obicetrapib/ezetimib fixed-dose combination (Evlarco) in Europe, based on positive Phase 3 trial data from BROADWAY, BROOKLYN, and TANDEM studies.
Clinical Trial Data
Phase
Phase_3
Primary Endpoint
Met
Outcome Details
Positive CHMP opinion with recommendation for marketing authorization approval for obicetrapib monotherapy and obicetrapib/ezetimib fixed-dose combination in Europe
Importance:8/10
Sentiment:
0.85
regulatory approvalCHMP positive opinionEuropeobicetrapibPhase 3 datamarketing authorization
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Published by PR Newswire Biotech on July 26, 2026 5:59 PM