The European Commission has authorised Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg + ezetimibe 10 mg) — the first global approvals for obicetrapib — to treat primary hypercholesterolaemia and mixed dyslipidaemia in Europe. Phase III data (BROADWAY, BROOKLYN, TANDEM) showed LDL‑C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination, with a safety profile similar to placebo. Menarini will market the medicines in Europe; NewAmsterdam will receive tiered royalties and may earn up to €833M in milestones while additional Phase III trials continue.
EU Grants First Global Approval for Obicetrapib: Menarini and NewAmsterdam Launch Ubeslo and Evlarco
In Phase Ib
The European Commission has granted marketing authorisation for two obicetrapib-based medicines developed by NewAmsterdam Pharma and Menarini Group: Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (fixed‑dose combination of obicetrapib 10 mg + ezetimibe 10 mg).
Scope of Approval
The authorisation permits both products to treat adults with primary hypercholesterolaemia — including heterozygous familial and non‑familial forms — and patients with mixed dyslipidaemia. This decision follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and represents the first regulatory approval for obicetrapib anywhere in the world.
Clinical Evidence
Approval was supported by data from NewAmsterdam’s Phase III programme, notably the BROADWAY, BROOKLYN and TANDEM trials. Across these studies, obicetrapib produced statistically significant reductions in low‑density lipoprotein cholesterol (LDL‑C):
- Obicetrapib monotherapy lowered LDL‑C by up to 40% versus placebo;
- The obicetrapib + ezetimibe fixed‑dose combination reduced LDL‑C by approximately 50% versus placebo.
Investigators reported a safety profile for obicetrapib that was similar to placebo in the Phase III trials.
Commercial Agreement
Under the collaboration, Menarini holds exclusive rights to market obicetrapib across Europe and is responsible for regulatory and commercial activities in the region. NewAmsterdam will receive tiered double‑digit royalties on European sales and may be eligible for up to €833 million in milestone payments.
Ongoing Development
Both companies continue to evaluate obicetrapib in additional Phase III studies, including PREVAIL, REMBRANDT and RUBENS, to further define its clinical profile and potential indications.
Michael Davidson, CEO of NewAmsterdam Pharma: "The EC approval of Ubeslo and Evlarco marks a major milestone as the first regulatory approval of obicetrapib globally. This first‑in‑class approval reflects the strength of the clinical evidence and our commitment to addressing an important unmet need for patients who struggle to reach recommended LDL‑C targets."
Drug Profile
Obicetrapib is an oral, low‑dose cholesteryl ester transfer protein (CETP) inhibitor designed to lower LDL cholesterol in patients who do not achieve adequate LDL‑C reduction with existing therapies. The fixed‑dose combination with ezetimibe aims to enhance LDL‑C lowering through complementary mechanisms.
Additional Note: In a separate development, in March 2025 Menarini and its subsidiary Stemline Therapeutics announced a partnership with VisualDx to improve detection of blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Source: Hospital Management (GlobalData brand). All factual details and figures are retained from the original reporting.
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