RegulatoryJul 24, 2026, 08:07 AM
NewAmsterdam Pharma & Menarini Get Positive CHMP Opinion for Ubeslo, Evlarco
AI Summary
NewAmsterdam Pharma Co N.V. and its partner Menarini Group have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This recommendation is for marketing authorization of Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib plus ezetimibe fixed-dose combination) for patients with primary hypercholesterolemia in Europe. The positive opinion is supported by data from Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed significant LDL-C reductions. A final decision from the European Commission is anticipated in the second half of 2026.
Key Highlights
- Received positive CHMP opinion for Ubeslo® (obicetrapib monotherapy) and Evlarco® (FDC).
- Recommendation supports marketing authorization in Europe for primary hypercholesterolemia.
- Opinion based on positive Phase 3 BROADWAY, BROOKLYN, and TANDEM clinical data.
- Obicetrapib monotherapy demonstrated up to 40% LDL-C reductions.
- Obicetrapib FDC achieved approximately 50% LDL-C reductions.
- European Commission final decision on marketing authorization expected in 2H26.
- NewAmsterdam Pharma is eligible for tiered double-digit royalties and up to €833 million in milestones.
- Menarini Group holds exclusive commercialization rights for obicetrapib in Europe.
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