RegulatoryJul 24, 2026, 08:05 AM
NewAmsterdam Pharma's Obicetrapib Gets Positive CHMP Opinion
AI Summary
NewAmsterdam Pharma Company N.V. announced that the European Medicines Agency's CHMP adopted a positive opinion recommending marketing authorization for Ubeslo® (obicetrapib monotherapy) and Evlarco® (obicetrapib/ezetimibe fixed-dose combination). This recommendation is for patients with primary hypercholesterolemia, including heterozygous familial and non-familial or mixed dyslipidemia. The positive opinion is based on data from Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which demonstrated significant LDL-C reductions. A final decision from the European Commission is anticipated in the second half of 2026, with partner Menarini Group holding exclusive commercialization rights in Europe.
Key Highlights
- CHMP recommends marketing authorization for Ubeslo® (obicetrapib) and Evlarco® (obicetrapib/ezetimibe FDC).
- Recommendation for primary hypercholesterolemia, including HeFH and mixed dyslipidemia.
- Supported by positive Phase 3 BROADWAY, BROOKLYN, and TANDEM trial data.
- Obicetrapib monotherapy showed up to 40% LDL-C reduction versus placebo.
- Obicetrapib/ezetimibe FDC showed approximately 50% LDL-C reduction versus placebo.
- European Commission decision on marketing authorization expected in 2H26.
- Menarini Group holds exclusive commercialization rights for obicetrapib in Europe.
- NewAmsterdam Pharma to receive tiered double-digit royalties and up to €833 million in milestones.
Price Impact
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