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NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) received European Commission approval for Ubeslo (10 mg obicetrapib) and Evlarco (10 mg obicetrapib and 10 mg ezetimibe) on September 21. These products, which lower low-density lipoprotein cholesterol (LDL-C), received their first global approvals for adults with primary high cholesterol or mixed lipid disorders. Menarini holds exclusive European commercialization rights, granting NAMS tiered royalties ranging from low double-digit to mid-20% on net sales. The agreement includes up to €833 million in potential clinical, regulatory, and commercial milestone payments.
The products showed LDL-C reductions of up to 40% with obicetrapib and approximately 50% with the ezetimibe combination in Phase 3 studies. The PREVAIL trial, involving over 9,500 patients, will evaluate whether obicetrapib reduces major cardiovascular events, with an interim analysis expected in the fourth quarter of 2026.
The products showed LDL-C reductions of up to 40% with obicetrapib and approximately 50% with the ezetimibe combination in Phase 3 studies. The PREVAIL trial, involving over 9,500 patients, will evaluate whether obicetrapib reduces major cardiovascular events, with an interim analysis expected in the fourth quarter of 2026.