NewAmsterdam Pharma and Menarini Group Receive Positive CHMP Opinion Recommending Marketing Authorization for Ubeslo® (Obicetrapib Monotherapy) and Evlarco® (Obicetrapib Plus Ezetimibe Fixed-Dose Combination)
NewAmsterdam Pharma and partner Menarini Group announced a positive CHMP opinion recommending marketing authorization for Ubeslo (obicetrapib monotherapy) and Evlarco (obicetrapib/ezetimibe FDC) in Europe. The recommendation is backed by Phase 3 data showing LDL-C reductions of up to 50%, with a final European Commission decision expected in the second half of 2026.
Key figures
- Drug Name
- Ubeslo (obicetrapib) and Evlarco
- Phase Of Trial
- Phase 3
- Royalty rate
- low double-digits to mid-twenties
- Ldl reduction combo
- approximately 50%
- Potential milestones eur
- €833 million
- Ldl reduction monotherapy
- up to 40%
AI analysis
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