EU Commission approves NewAmsterdam Pharma’s obicetrapib for primary hypercholesterolemia

EU regulators granted marketing authorization for Ubeslo (obicetrapib) and Evlarco (obicetrapib-ezetimibe) to treat primary hypercholesterolemia.

The approval covers heterozygous familial or non-familial disease, as well as mixed dyslipidemia, and is the first global clearance for obicetrapib.

Phase 3 data showed up to 40% LDL-C reduction on monotherapy and about 50% with the fixed-dose combination versus placebo.

Menarini holds exclusive European commercialization rights, and NewAmsterdam is eligible for tiered double-digit royalties up to about 25%. The deal also includes up to EUR 833 million in potential milestone payments tied to clinical, regulatory and commercial triggers.