European Commission approves Ubeslo and Evlarco for high LDL cholesterol
The European Commission has approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia, marking the first regulatory approval worldwide for obicetrapib.
Ubeslo contains obicetrapib as monotherapy, while Evlarco combines obicetrapib with ezetimibe to provide an additional LDL-cholesterol-lowering option for eligible patients.
The decision introduces a new oral lipid-lowering therapy in Europe and broadens treatment options for patients who require further reduction in LDL cholesterol.
Field | Content |
Alert Type | Approval |
Drug Name | Obicetrapib |
Brand Names | Ubeslo; Evlarco |
Companies | NewAmsterdam Pharma; Menarini Group |
Regulatory Authority | European Commission |
Approval Type | EU marketing authorisation |
Indication | Primary hypercholesterolaemia or mixed dyslipidaemia |
Therapy Area(s) | Cardiology; lipid management; cardiometabolic disease |
Technology or Modality | Oral lipid-lowering therapy |
Products | Ubeslo: obicetrapib monotherapy; Evlarco: obicetrapib plus ezetimibe fixed-dose combination |
Geography | European Union |
What Happened | The European Commission approved Ubeslo and Evlarco for treatment of primary hypercholesterolaemia or mixed dyslipidaemia. |
Why It Matters | The decision represents the first regulatory approval worldwide for obicetrapib and introduces another oral option for patients requiring additional LDL-cholesterol reduction. |
Supporting Context | Evlarco combines obicetrapib with ezetimibe, while Ubeslo provides obicetrapib as a single-agent treatment. |
Key Takeaway | Obicetrapib has received its first global regulatory approval through EU authorisation of Ubeslo and Evlarco. |
What to Watch | European pricing and reimbursement, launch timing and positioning alongside existing lipid-lowering therapies. |
Primary Source | Menarini Group |
Relevant Date | 21 September 2026 |
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