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NewAmsterdam Pharma wins European approval for cholesterol drugs
The European Commission cleared two first-in-global products, including a combination tablet, with expected LDL-C reductions of up to 40% to 50% versus placebo in Phase 3 data.
NewAmsterdam Pharma Company N.V. said the European Commission approved Ubeslo, which contains 10 mg of obicetrapib, and Evlarco, combining 10 mg of obicetrapib with 10 mg of ezetimibe. The company said the approvals, announced September 21, mark the products' first global clearances.
The approved treatments are intended for adults with primary high cholesterol or mixed lipid disorders, with eligibility depending on existing therapy and statin tolerance. NewAmsterdam said the medicines lower low-density lipoprotein cholesterol, commonly called bad cholesterol, and the approval announcement cited statistically significant LDL-C reductions versus placebo of up to 40% with obicetrapib and about 50% with the ezetimibe combination across its Phase 3 program.
According to the company, the Phase 3 studies included patients already on maximally tolerated cholesterol-lowering treatment, creating an opportunity for patients who need additional LDL-C reduction. It also said the oral combination approach could simplify regimens for eligible patients who would otherwise take separate pills.
NewAmsterdam will commercialize through Menarini, which has exclusive European commercialization rights. The company is entitled to tiered royalties ranging from low double-digit percentages to the mid-20% range on net sales in the licensed territory, and it said the deal includes up to an additional €833 million in potential milestone payments tied to clinical, regulatory, and commercial achievements, alongside royalty-based participation in sales growth.