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NewAmsterdam Pharma Gets EU Approval for Ubeslo, Evlarco

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NewAmsterdam Pharma (NAMS) said Monday that the European Commission approved Ubeslo, an obicetrapib monotherapy, and Evlarco, an obicetrapib-ezetimibe combination, for certain patients with elevated cholesterol.

The approvals mark the first regulatory authorization for obicetrapib worldwide and follow a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, the company said.

The applications were supported by Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib monotherapy and about 50% with the combination therapy versus placebo.

NewAmsterdam and Menarini are advancing obicetrapib in additional Phase 3 trials, including PREVAIL, REMBRANDT and RUBENS, it added.

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