Shots:
- The CHMP has recommended Ubeslo (obicetrapib 10mg) & Evlarco (10mg obicetrapib + 10mg ezetimibe FDC) for pts with primary hypercholesterolemia, both HeFH & non-familial or mixed dyslipidemia; EC decision expected in H2’26 & will be valid across 30 EEA states
- Opinion was supported by extensive clinical data assessing obicetrapib, incl. the P-III (BROADWAY, BROOKLYN & TANDEM) trials, which showed up to 40% LDL-C reductions with Ubeslo vs PBO & ~50% with Evlarco vs PBO
- NewAmsterdam & Menarini continue advancing obicetrapib through P-III trials, incl. the cardiovascular outcomes PREVAIL study, as well as the REMBRANDT & RUBENS trials
Ref: Menarini | Image: NewAmsterdam & Menarini | Press Release
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