EU approves NewAmsterdam and Menarini's obicetrapib drugs

The European Commission has granted marketing authorization for two cholesterol-lowering drugs developed by NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS) and its partner Menarini Group, marking the first regulatory approval of obicetrapib anywhere in the world.

The approvals cover Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination), both indicated for adults with primary hypercholesterolaemia, including heterozygous familial and non-familial forms, or mixed dyslipidaemia.

The decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and is supported by data from the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials. Those trials showed LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with the obicetrapib-ezetimibe combination versus placebo, with a tolerability profile described as comparable to placebo.

Obicetrapib is an oral, once-daily CETP inhibitor. Under the companies' licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe. NewAmsterdam is entitled to tiered royalties ranging from low double-digit to mid-twenties percentages on net sales in the Menarini territory, plus up to an additional €833 million tied to clinical, regulatory, and commercial milestones.

NewAmsterdam and Menarini said they continue to advance obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial that completed enrollment of more than 9,500 patients in April 2024, as well as the REMBRANDT and RUBENS trials.

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