The European Commission (EC) has granted marketing authorisation to NewAmsterdam Pharma and Menarini Group for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination).
The authorisation allows both treatments to be used for patients with primary hypercholesterolaemia, including those with heterozygous familial and non-familial forms or mixed dyslipidaemia.
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This is said to be the first regulatory approval anywhere in the world for obicetrapib.
The EC’s decision follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use.
Backing for the approval comes from data in NewAmsterdam’s clinical development programme, including Phase III BROADWAY, BROOKLYN and TANDEM trials.
Results from these studies showed statistically significant reductions in Low-density lipoprotein (LDL) cholesterol, with obicetrapib monotherapy reducing LDL-C by up to 40% compared to placebo, and the combination with ezetimibe reducing it by about 50%.
The safety profile was reported as similar to placebo.
Under the collaboration, Menarini holds exclusive rights to market obicetrapib in Europe and is responsible for regulatory and commercial activities there.
NewAmsterdam will receive tiered double-digit royalties and could qualify for up to €833m in milestone-related payments.
Both firms continue to evaluate obicetrapib in ongoing Phase III trials, including PREVAIL, REMBRANDT, and RUBENS.
Obicetrapib is being developed as a low-dose, oral Cholesteryl ester transfer protein (CETP) inhibitor for lowering LDL cholesterol in patients who do not respond adequately to existing treatments.
NewAmsterdam Pharma CEO Michael Davidson said: “The EC approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies.
“This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine.
“Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world.”
In March 2025, the Menarini Group and its subsidiary Stemline Therapeutics announced a partnership with VisualDx to enhance the detection of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
